A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes

A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes
Title:
A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes
Other Titles:
Clinical Nutrition
Publication Date:
28 January 2013
Citation:
Ataie-Jafari A, Loke SC, Rahmat AB, et al. A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes. Clin Nutr. 2013;32(6):911‐917. doi:10.1016/j.clnu.2013.01.012
Abstract:
Background & aims: This participant-blinded parallel-group randomized placebo-controlled study demonstrated that alfacalcidol (vitamin D analogue) preserves beta cell function in newly diagnosed type 1 diabetes (T1DM) in children. Methods: Subjects from outpatient clinic were randomized to intervention and control groups. Inclusion: (1) age 8e15, (2) T1DM, (3) duration <8 weeks, (4) no chronic diseases, (5) stable diet. Exclusion: (1) vitamin D, calcium supplements or fortified foods, (2) hypercalcemia. Intervention group received alfacalcidol 0.25 mg twice daily, while control group received placebo. Insulin given physician-titrated to blood glucose. Safety monitored by serum calcium and phosphate. Beta cell function assessed at 0, 3, 6 months using fasting C-peptide (FCP) and daily insulin dosage per body weight (DID). Primary outcome measured using multivariate repeated measures GLM-ANOVA, with FCP and DID as primary measures and age, gender, sunlight exposure, 25-hydroxy vitamin D, and HbA1c as covariates. Results: Of 61 subjects, 7 dropped out. GLM-ANOVA showed that groups were different (p ¼ 0.019, Etasquared ¼ 0.087), with no significant covariates. FCP was higher and DID lower in the intervention group, with males having stronger responses to alfacalcidol (p ¼ 0.001). No adverse effects were observed. Conclusions: The study confirmed that alfacalcidol can safely preserve beta cell function in newly diagnosed T1DM in children, with a stronger effect in males
License type:
http://creativecommons.org/licenses/by-nc-nd/4.0/
Funding Info:
The study was run using internal funding from the Endocrinology and Metabolism Research Center (EMRC), Tehran University of Medical Sciences.
Description:
ISSN:
0261-5614
1532-1983
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