Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

February 9, 2024 updated by: Jaeb Center for Health Research
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Not yet recruiting
        • Yale University School Of Medicine
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30324
    • Illinois
    • Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40508
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Not yet recruiting
        • Tulane University
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Massachusetts
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine (St. Louis)
        • Contact:
        • Contact:
    • New York
      • Hawthorne, New York, United States, 10532
      • New Hyde Park, New York, United States, 11040
    • Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
    • Texas
    • Virginia
      • Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adults 18 and older with a confirmed diagnostic of cystic fibrosis, identified genotypes (when available), no prior solid organ transplant, and not pregnant or planning on becoming pregnant during the 1st year of the study. Participants receiving a lung transplantation while enrolled in the study will not need to be withdrawn.

Description

Inclusion Criteria:

  • Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.
  • Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.
  • Both cohorts match by age, gender, race and CFTR genotype severity.

Exclusion Criteria:

  • No prior solid organ transplantation
  • No initiation of an investigation drug within 28 days prior to and including Visit 1
  • No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
  • No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Visit 1.
  • For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
  • No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit.
  • Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Forced expiratory volume in 1 second (FEV1) <60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used.
Diagnostic test: BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI
Diagnostic test: Hand-grip strength
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.
Diagnostic test: Short physical performance battery (SPPB)
This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) Balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) Two 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).
Diagnostic test: BIA Sub-study
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).
Other: Psychosocial questionnaire: PHQ-8
This is an 8-item scale that measures depressive symptoms over the past two weeks.
Other: Psychosocial questionnaire: GAD-7
This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.
Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.
Other: Psychosocial questionnaire: CF Fatalism Scale
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items.
Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.
Other: Oral glucose tolerance testing (OGTT)
For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.
Device: Continuous glucose monitoring (CGM)
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data.
Diagnostic test: Chest CT scans (When available within the past 6 months in medical records)
Standard of Care chest CT images will be drawn from the medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch. Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.
Diagnostic test: Hologic Dual X-Ray Absorptiometry (DXA)
DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. This will be used as the gold standard from which to validate BIA and MAMC.
Diagnostic test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient.
Other: Respiratory symptom questionnaire: CRISS
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.
Diagnostic test: Spirometry
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.
Diagnostic test: Anthropometric Measurements
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.
Diagnostic test: Six-minute walk Test
This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes.The total distance walked in that time will be measured.
Diagnostic test: Sit-to-Stand Test
This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.
Diagnostic test: Accelerometry to assess physical activity
Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. Participants will be able to keep their accelerometers.
Other: Gastrointestinal (GI) and nutrition questionnaires:
Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).
Other: 12-month Questionnaire
A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants at the end of the study.
Diagnostic test: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.
Other: Psychosocial questionnaire: Additional Health Questionnaire
Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.
Cohort 2
FEV1 ≥60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation).
Diagnostic test: BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI
Diagnostic test: Hand-grip strength
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.
Diagnostic test: Short physical performance battery (SPPB)
This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) Balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) Two 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).
Diagnostic test: BIA Sub-study
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).
Other: Psychosocial questionnaire: PHQ-8
This is an 8-item scale that measures depressive symptoms over the past two weeks.
Other: Psychosocial questionnaire: GAD-7
This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.
Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.
Other: Psychosocial questionnaire: CF Fatalism Scale
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items.
Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.
Other: Oral glucose tolerance testing (OGTT)
For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.
Device: Continuous glucose monitoring (CGM)
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data.
Diagnostic test: Chest CT scans (When available within the past 6 months in medical records)
Standard of Care chest CT images will be drawn from the medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch. Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.
Diagnostic test: Hologic Dual X-Ray Absorptiometry (DXA)
DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. This will be used as the gold standard from which to validate BIA and MAMC.
Diagnostic test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient.
Other: Respiratory symptom questionnaire: CRISS
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.
Diagnostic test: Spirometry
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.
Diagnostic test: Anthropometric Measurements
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.
Diagnostic test: Six-minute walk Test
This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes.The total distance walked in that time will be measured.
Diagnostic test: Sit-to-Stand Test
This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.
Diagnostic test: Accelerometry to assess physical activity
Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. Participants will be able to keep their accelerometers.
Other: Gastrointestinal (GI) and nutrition questionnaires:
Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).
Other: 12-month Questionnaire
A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants at the end of the study.
Diagnostic test: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.
Other: Psychosocial questionnaire: Additional Health Questionnaire
Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between DXA lean mass index and BMI
Time Frame: Baseline and 1 year
Estimate and compare correlation between lean mass index from DXA (kg/m2) and BMI (kg/m2)
Baseline and 1 year
Correlation between DXA lean mass index and mid-arm muscle circumference
Time Frame: Baseline and 1 year
Estimate and compare correlation between lean mass index from DXA (kg/m2) and mid-arm muscle circumference (cm)
Baseline and 1 year
Correlation between DXA lean mass index and hand-grip strength
Time Frame: Baseline and 1 year
Estimate and compare correlation between lean mass index from DXA (kg/m2) and hand-grip strength (kg)
Baseline and 1 year
Correlation between DXA lean mass index and the 6-minute walk distance traveled
Time Frame: Baseline and 1 year
Estimate and compare correlation between lean mass index from DXA (kg/m2) and 6-minute walk (distance traveled in six minutes)
Baseline and 1 year
Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions
Time Frame: Baseline and 1 year
Estimate and compare correlation between lean mass index from DXA (kg/m2) and 1-minute sit-to-stand (number of sit-to-stand repetitions in one minute)
Baseline and 1 year
Correlation between DXA lean mass index and Short Physical Performance Battery frailty score
Time Frame: Baseline and 1 year
Estimate and compare correlation between lean mass index from DXA (kg/m2) and Short Physical Performance Battery frailty score (total points)
Baseline and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize lean mass index from DXA cross-sectionally and longitudinally
Time Frame: Baseline and 1 year
Characterize lean mass index from DXA cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Baseline and 1 year
Characterize BMI cross-sectionally and longitudinally
Time Frame: Baseline and 1 year
Characterize lean mass index from BMI cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Baseline and 1 year
Characterize mid-arm measurement circumference cross-sectionally and longitudinally
Time Frame: Baseline and 1 year
Characterize lean mass index from mid-arm circumference measurements cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Baseline and 1 year
Characterize hand-grip strength cross-sectionally and longitudinally
Time Frame: Baseline and 1 year
Characterize hand-grip strength cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Baseline and 1 year
Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally
Time Frame: Baseline and 1 year
Characterize the 1 minute sit-to-stand repetitions cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Baseline and 1 year
Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally
Time Frame: Baseline and 1 year
Characterize the 6-minute walk test distance traveled cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Baseline and 1 year
Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally
Time Frame: Baseline and 1 year
Characterize the Short Physical Performance Battery frailty score cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Baseline and 1 year
Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
Baseline and 1 year
Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
Baseline and 1 year
Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
Baseline and 1 year
Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
Baseline and 1 year
Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
Baseline and 1 year
Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
Baseline and 1 year
Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
Baseline and 1 year
Evaluate mean glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate mean glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Baseline and 1 year
Evaluate % time above 140 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate % time above 140 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Baseline and 1 year
Evaluate % time above 180 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate % time above 180 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Baseline and 1 year
Evaluate peak glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate peak glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Baseline and 1 year
Evaluate % time below 70 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate % time below 70 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Baseline and 1 year
Evaluate % time below 54 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate % time below 54 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Baseline and 1 year
Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
Baseline and 1 year
Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60%
Time Frame: Baseline and 1 year
Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60%
Baseline and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Investigators

  • Principal Investigator: Adam Stein, Northwestern
  • Principal Investigator: Jessica Alvarez, Emory University
  • Principal Investigator: Melissa Putman, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 28, 2022

First Posted (Actual)

December 6, 2022

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRONG-CF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on BMI and lean mass index from DXA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe