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


Asal, Ataie Jafari and Loke, Seng Cheong and Rahmat, Asmah and Larijani, Bagher and Abbasi, Farzaneh and Leow, Melvin Khee Shing and Yassin, Zaitun (2013) A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes. Clinical Nutrition, 32 (6). pp. 911-917. ISSN 0261-5614; ESSN: 1532-1983


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 8–15, (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 μg 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 = 0.019, Eta-squared = 0.087), with no significant covariates. FCP was higher and DID lower in the intervention group, with males having stronger responses to alfacalcidol (p = 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.

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Additional Metadata

Item Type: Article
Divisions: Faculty of Medicine and Health Science
Institute of Gerontology
DOI Number: https://doi.org/10.1016/j.clnu.2013.01.012
Publisher: Elsevier BV
Keywords: C-Peptide; Diabetes mellitus; Type 1; Hydroxycholecalciferols; Insulin-secreting cells; Iran; Randomized controlled trial
Depositing User: Nurul Ainie Mokhtar
Date Deposited: 22 May 2015 02:07
Last Modified: 02 Sep 2015 04:54
Altmetrics: http://www.altmetric.com/details.php?domain=psasir.upm.edu.my&doi=10.1016/j.clnu.2013.01.012
URI: http://psasir.upm.edu.my/id/eprint/29701
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