Trial reportJournal of translational medicine2025
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.
Trial report in Journal of translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06283615 (Effect of Vitamin D Supplementation on Skeletal Muscle Function and Quality of Life in Patients With Chronic Intestinal Failure/Insufficiency), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Vitamin D Supplementation on Skeletal Muscle Function and Quality of Life in Patients With Chronic Intestinal Failure/Insufficiency: A Randomised Clinical Trial
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
backgroundVitamin 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.
methodsThis 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.
resultsEighty-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). Compared with the control group, the vitamin D group showed clinically meaningful improvements in the appendicular skeletal muscle mass index, handgrip strength, 6-meter walking speed, and the SF-36 physical component summary score (all p < 0.05 after Bonferroni correction). No other clinically significant differences were observed between the groups in the remaining secondary clinical and safety endpoints.
conclusionHigh-dose intramuscular vitamin D2 supplementation for 10 weeks was significantly associated with improved skeletal muscle mass, function, and QoL in patients with CIF. THIS
trial registrationClinicalTrials.Gov Identifier: NCT06283615. Registered 11 March 2024, https://clinicaltrials.gov/study/NCT06283615 .
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