An interventional study of Vitamin D in Intestinal Failure, sponsored by Jinling Hospital, China. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Treatment
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.
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's enrollment of 84 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Vitamin D
Control group: received appearance-matched placebo plus standard care, no additional vitamin D intervention therapy.
Vitamin D2 injection
Also known as: Vitamin D2
Quality of life score
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.
Time frame: up to 12 weeks
Muscle function status
Including hand grip strength(kg); Appendicular skeletal muscle mass index (ASMI) = limb muscle mass (kg)/height (m)2；6 meters walking speed(m/s)
Time frame: up to 12 weeks
Serum vitamin D levels
Serum 25 hydroxyvitamin D levels
Time frame: up to 12 weeks
Hepatic and renal function
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.
Time frame: up to 12 weeks
Bone mineral density
Bone mineral density by DXA
Time frame: up to 12 weeks
Thyroid and parathyroid-related hormones
Including surum total triiodothyroxine, total tetraiodothyroxine, free triiodothyronine, free tetraiodothyroxine, thyroid stimulating hormone, parathyroid hormone and calcitonin.
Time frame: up to 12 weeks
Nutritional status indicators
Including body weight (kg), serum albumin (g/L) and prealbumin (mg/L) levels.
Time frame: up to 12 weeks
Number of participants with treatment-related adverse events
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.
Time frame: up to 12 weeks
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D