CompletedNot Applicable

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

China84 participantsStarted 2024-03-12

Plain-language summary

Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: received placebo plus standard care, no additional vitamin D intervention therapy. Vitamin D group: In addition to the standard care, 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Those who did not meet the inclusion criteria, or who were deemed unfit by their physician to participate in this study
✕. Primary hypothyroidism or parathyroidism
✕. Patients suffering from allergic diseases, are allergic, have a history of drug sensitivity similar to the structure of the study drug
✕. Patients with primary diabetes
✕. Patients with mental illness, inability to cooperate or consciousness disorders
✕. Patients with contraindications of experimental drugs
✕. Patients with a suspected or confirmed history of substance abuse
✕. Immune deficiency, use of immunosuppressants and hormones

What they're measuring

Quality of life score

Timeframe: up to 12 weeks

Muscle function status

Timeframe: up to 12 weeks

Trial details

NCT IDNCT06283615

SponsorJinling Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

View on ClinicalTrials.gov More Intestinal Failure trials