Clinical trial NCT06283615: Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency
Official title: Effect of Vitamin D Supplementation on Skeletal Muscle Function and Quality of Life in Patients With Chronic Intestinal Failure/Insufficiency: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intestinal Failure
Keywords: Vitamin D
Quality of life
Muscle function
Chronic intestinal failure
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Quality of life score
timeFrame: up to 12 weeks
measure: Muscle function status
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Serum vitamin D levels
timeFrame: up to 12 weeks
measure: Hepatic and renal function
timeFrame: up to 12 weeks
measure: Bone mineral density
timeFrame: up to 12 weeks
measure: Thyroid and parathyroid-related hormones
timeFrame: up to 12 weeks
measure: Nutritional status indicators
timeFrame: up to 12 weeks
measure: Number of participants with treatment-related adverse events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Nanning
country: China
facility: Xinying Wang
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Xinying Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lepus CA, Samela K, Emerick KM, Mokha JS. Vitamin D status in children with intestinal failure who have achieved enteral autonomy. Nutr Clin Pract. 2021 Dec;36(6):1284-1289. doi: 10.1002/ncp.10685. Epub 2021 Jun 23.
citation: Wozniak LJ, Bechtold HM, Reyen LE, Hall TR, Vargas JH. Vitamin D deficiency in children with intestinal failure receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2015 May;39(4):471-5. doi: 10.1177/0148607114527135. Epub 2014 Mar 14.
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