Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency

March 21, 2024 updated by: Wang Xinying, Jinling Hospital, China

Effect of Vitamin D Supplementation on Skeletal Muscle Function and Quality of Life in Patients With Chronic Intestinal Failure/Insufficiency: A Randomised Clinical Trial

Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.

The primary and secondary outcomes will be collected.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients with chronic intestinal failure/insufficiency were randomly assigned to one of two groups, Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.

The primary and secondary outcomes will be collected.

Study Type

Interventional

Enrollment (Estimated)

84

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 Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanning, Jiangsu, China, 210002
        • Recruiting
        • Xinying Wang
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xinying Wang, MD
        • Sub-Investigator:
          • Xuejin Gao, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed consent was obtained from patients or their legal representatives for participation in this study
  2. Patients 18 years of age or older, under 70 years of age, chronic intestinal failure/insufficiency
  3. Serum 25(OH)D level < 30.0 ng/ml
  4. Vital signs are stable

Exclusion Criteria:

  1. Those who did not meet the inclusion criteria, or who were deemed unfit by their physician to participate in this study
  2. Primary hypothyroidism or parathyroidism
  3. Patients suffering from allergic diseases, are allergic, have a history of drug sensitivity similar to the structure of the study drug
  4. Patients with primary diabetes
  5. Patients with mental illness, inability to cooperate or consciousness disorders
  6. Patients with contraindications of experimental drugs
  7. Patients with a suspected or confirmed history of substance abuse
  8. Immune deficiency, use of immunosuppressants and hormones
  9. Pregnant and lactating women
  10. Have taken any vitamin D supplements in the last 6 months
  11. Have taken any medication in the last 6 months that affects vitamin D metabolism (e.g., phenytoin, phenobarbital, rifampicin)
  12. Patients who participated in a drug trial (including the drug in the trial) within 3 months before the trial
  13. Sponsors or investigators directly involved in the trial or their family members
  14. The researcher believes that there is any reason not to be accepted

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D
Experimental group: In addition to conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
Drug: Vitamin D
Vitamin D2 injection
Other Names:
  • Vitamin D2
No Intervention: Control
Control group: routine treatment only, no additional vitamin D intervention therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: up to 12 weeks
Quality of life was assessed using the SF-36 score from the date of randomization until the end of the 12-week intervention weeks. SF-36 consists of eight dimensions, each of which is measured on a scale of 0-100, with higher scores indicating a better quality of life.
up to 12 weeks
Muscle function status
Time Frame: up to 12 weeks
Including hand grip strength(kg); Appendicular skeletal muscle mass index (ASMI) = limb muscle mass (kg)/height (m)2；6 meters walking speed(m/s)
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum vitamin D levels
Time Frame: up to 12 weeks
Serum 25 hydroxyvitamin D levels
up to 12 weeks
Hepatic and renal function
Time Frame: up to 12 weeks
Liver function includes the following indicators: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), direct and indirect bilirubin, γ-glutamyltranspeptidase (γ-GT) and alkaline phosphatase (ALP). Kidney function includes the following indicators: serum creatinine and blood urea nitrogen.
up to 12 weeks
Bone mineral density
Time Frame: up to 12 weeks
Bone mineral density by DXA
up to 12 weeks
Thyroid and parathyroid-related hormones
Time Frame: up to 12 weeks
Including surum total triiodothyroxine, total tetraiodothyroxine, free triiodothyronine, free tetraiodothyroxine, thyroid stimulating hormone, parathyroid hormone and calcitonin.
up to 12 weeks
Nutritional status indicators
Time Frame: up to 12 weeks
Including body weight (kg), serum albumin (g/L) and prealbumin (mg/L) levels.
up to 12 weeks
Number of participants with treatment-related adverse events
Time Frame: up to 12 weeks

Occurrence of hypercalcemia and hyperphosphatemia during intervention and follow-up. The blood calcium concentration > 2.75 mmol/L is called hypercalcemia. Normal human blood phosphorus concentration is relatively stable (normal reference value 0.87~1.45mmol/ L), when the determination result is greater than the normal reference value of 1.45mmol/ L, it can be diagnosed as hyperphosphatemia.

Occurrences of kidney stones during intervention and follow-up. Kidney stones are examined by ultrasound.

Incidence of fall-related fractures during intervention and follow-up.
up to 12 weeks

Collaborators and Investigators

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

Sponsor

Jinling Hospital, China

Investigators

  • Principal Investigator: Xinying Wang, MD, Jinling Hospital, China

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 (Estimated)

March 12, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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