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Completed

NCT Number: NCT06283615

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

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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Key information

Conditions

Intestinal Failure Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinying Wang

Nanning, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnant and lactating women
  • Have taken any vitamin D supplements in the last 6 months
  • Have taken any medication in the last 6 months that affects vitamin D metabolism (e.g., phenytoin, phenobarbital, rifampicin)
  • Patients who participated in a drug trial (including the drug in the trial) within 3 months before the trial
  • Sponsors or investigators directly involved in the trial or their family members
  • The researcher believes that there is any reason not to be accepted

Treatment and study plan

Vitamin D

Drug

Vitamin D2 injection

Other names: Vitamin D2

Primary outcomes

  1. Quality of life score

    Time frame: 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.

  2. Muscle function status

    Time frame: 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)

Secondary outcomes

  1. Serum vitamin D levels

    Time frame: up to 12 weeks

    Serum 25 hydroxyvitamin D levels

  2. Hepatic and renal function

    Time frame: 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.

  3. Bone mineral density

    Time frame: up to 12 weeks

    Bone mineral density by DXA

  4. Thyroid and parathyroid-related hormones

    Time frame: up to 12 weeks

    Including surum total triiodothyroxine, total tetraiodothyroxine, free triiodothyronine, free tetraiodothyroxine, thyroid stimulating hormone, parathyroid hormone and calcitonin.

  5. Nutritional status indicators

    Time frame: up to 12 weeks

    Including body weight (kg), serum albumin (g/L) and prealbumin (mg/L) levels.

  6. Number of participants with treatment-related adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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