Vitamin D Oral Replacement in Asthma (VDORA1)

March 27, 2023 updated by: IDeA States Pediatric Clinical Trials Network
The overall objective of the study is to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.

In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period.

Across both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours/Alfred I DuPont Hospital for Children
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • Montana
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center/Children's Hospital and Medical Center
    • New Hampshire
      • Manchester, New Hampshire, United States, 03104
        • Dartmouth Hospital - Manchester
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Children's Hospital OU Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

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

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index greater than or equal to 85% for age and sex
  • Physician-diagnosed asthma
  • Ongoing relationship with asthma provider responsible for asthma care
  • Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test
  • Ability to swallow pills similar in size to the vitamin D preparation to be used
  • Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)
  • Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method
  • Child and parent, legal guardian, or caregiver must speak English or Spanish

Exclusion Criteria:

  • Known diseases of calcium metabolism or the parathyroid
  • History of renal insufficiency or kidney stones
  • Known liver failure or history of abnormal liver function tests
  • History of Williams syndrome, sarcoidosis, or granulomatous disease
  • Active tuberculosis
  • Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration
  • Clinical evidence of rickets
  • Taking supplemental vitamin D greater than equal to 1000 IU per day

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1, Cohort 1 Vitamin D3 oral regimen
Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Dietary supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation
Experimental: Part 1, Cohort 2 Vitamin D3 oral regimen
Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Dietary supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation
Experimental: Part 1, Cohort 3 Vitamin D3 oral regimen
Vitamin D: 6000 IU daily dose
Dietary supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation
Active Comparator: Part 1, Cohort 4 Vitamin D3 oral regimen
Vitamin D: 600 IU daily dose
Dietary supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation
Experimental: Part 2, Cohort A Vitamin D3 oral regimen
Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
Dietary supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation
Active Comparator: Part 2, Cohort B Vitamin D oral regimen
Vitamin D: 600 IU daily dose
Dietary supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Optimal Dosing Level to Use in Part 2
Time Frame: 20 weeks
Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.
20 weeks
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
Time Frame: 16 weeks
Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml
16 weeks

Collaborators and Investigators

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

Sponsor

IDeA States Pediatric Clinical Trials Network

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 30, 2019

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101 (Hamilton Integrated Research Ethics Board)
  • U24OD024957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be uploaded to Data and Specimen Hub (DASH) of NICHD

IPD Sharing Time Frame

Anticipated date of data upload is September 2023

IPD Sharing Access Criteria

per DASH requirements

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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.

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