Impact of Vitamin D on muscle function and quality of life in patients with chronic intestinal failure
Effect of Vitamin D Supplementation on Skeletal Muscle Function and Quality of Life in Patients With Chronic Intestinal Failure/Insufficiency: A Randomised Clinical Trial
This study tests if giving Vitamin D shots can help improve muscle strength and quality of life for people with chronic intestinal failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 1 site (Nanning, Jiangsu) |
| Trial ID | NCT06283615 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Vitamin D supplementation on muscle function and quality of life in patients suffering from chronic intestinal failure. Eligible participants are randomly assigned to either a Vitamin D group, receiving bi-weekly intramuscular injections of Vitamin D2, or a control group receiving standard treatment without additional Vitamin D. The study lasts for 12 weeks, during which primary and secondary outcomes related to muscle function and quality of life will be assessed. The aim is to determine if Vitamin D can improve these outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with chronic intestinal failure and low serum Vitamin D levels.
Not a fit: Patients with conditions such as primary hypothyroidism, parathyroidism, or those who have taken Vitamin D supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance muscle function and quality of life for patients with chronic intestinal failure.
How similar studies have performed: While there is limited data on this specific approach, other studies have suggested potential benefits of Vitamin D in improving muscle function in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanning, Jiangsu
- Xinying Wang — Nanning, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Xinying Wang, MD — Jinling Hospital, China
- Study coordinator: Xuejin Gao, MD
- Email: 547625433@qq.com
- Phone: +86 18251937684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.