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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2025-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intestinal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Vitamin D2 injection

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

Vitamin D2 injection

Intervention Type DRUG

Other Intervention Names

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Vitamin D2

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No