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

Not Applicable

Recruiting

• Conditions: Intestinal Failure
• Interventions: Drug: Vitamin D

• Registration Number: NCT06283615
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Study Start: 2024-03-12
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	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.

Primary Outcome Measures

Name	Time	Method
Muscle function status	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)
Quality of life score	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	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.
Serum vitamin D levels	up to 12 weeks	Serum 25 hydroxyvitamin D levels
Nutritional status indicators	up to 12 weeks	Including body weight (kg), serum albumin (g/L) and prealbumin (mg/L) levels.
Hepatic and renal function	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.
Bone mineral density	up to 12 weeks	Bone mineral density by DXA
Thyroid and parathyroid-related hormones	up to 12 weeks	Including surum total triiodothyroxine, total tetraiodothyroxine, free triiodothyronine, free tetraiodothyroxine, thyroid stimulating hormone, parathyroid hormone and calcitonin.

Trial Locations

Locations (1)

Xinying Wang; 🇨🇳 Nanning, Jiangsu, China