Effect of vitamin D supplementation on skeletal muscle function and quality of life in patients with chronic intestinal failure: a randomized controlled trial : Clean version
Abstract
BACKGROUND: Vitamin D deficiency is common in patients with chronic intestinal failure (CIF); however, the effectiveness of high-dose vitamin D supplementation remains unclear. This study aimed to investigate the effects of high-dose vitamin D supplementation on skeletal muscle mass, function, and quality of life (QoL) in patients with CIF. METHODS: This was a single-center, prospective, randomized, double-blind, placebo-controlled trial conducted at a tertiary hospital in China. Participants included individuals aged 18–70 years with chronic intestinal failure and vitamin D deficiency (serum 25(OH)D < 30 ng/ml). Eighty-four adult patients were randomly assigned (1:1) to either the vitamin D group (intramuscular injection of 600,000 units of vitamin D2 every two weeks for 10 weeks) or the control group (matched placebo). The primary outcomes were appendicular skeletal muscle mass index (assessed by bioelectrical impedance), handgrip strength, 6-meter walking speed, and quality of life (SF-36 scales) from the date of randomization to the end of the 12-week follow-up period. The analysis was performed on an intention-to-treat principle. RESULTS: Eighty-four patients were randomized to the control group (n = 42; mean age, 52.8 ± 15.6 years) or the vitamin D group (n = 42; mean age, 52.9 ± 16.2 years). At the 12-week follow-up, serum 25-hydroxyvitamin D levels were significantly higher in the vitamin D group than in the control group (96.7 ± 5.8 vs. 23.8 ± 4.1 ng/mL; p < 0.001).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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