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

Jinling Hospital, China

Status: Completed

Conditions: Intestinal Failure

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT06283615

2024-01-01

Details and patient eligibility

About

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.

Full description

Eligible patients with chronic intestinal failure/insufficiency were randomly assigned to one of 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 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Vitamin D

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D

Control

No Intervention group

Description:

Control group: received appearance-matched placebo plus standard care, no additional vitamin D intervention therapy.