Intestinal Failure
Conditions
Keywords
Vitamin D, Quality of life, Muscle function, Chronic intestinal failure
Brief summary
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.
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: 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.
Interventions
DRUGVitamin D
Vitamin D2 injection
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Serum vitamin D levels | up to 12 weeks | Serum 25 hydroxyvitamin D levels |
| 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. |
| 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. |
Countries
China
Outcome results
None listed