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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
Vitamin D2 injection
Xinying Wang
Nanning, Jiangsu, China
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.
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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