Supplementary materials for: Ergocalciferol in New-onset Type 1 diabetes: A Randomized Controlled Trial
AuthorsNwosu, Benjamin U.
Sharma, Rohit B.
Alonso, Laura C.
Lee, Austin F.
Barton, Bruce A.
UMass Chan AffiliationsDepartment of Population and Quantitative Health Sciences
Division of Pediatric Endocrinology, Department of Pediatrics
Keywordstype 1 diabetes
partial clinical remission
Endocrine System Diseases
Endocrinology, Diabetes, and Metabolism
Nutritional and Metabolic Diseases
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AbstractThis document consists of supplementary materials, including the 2021 Investigational Study Protocol, for a published manuscript. Manuscript abstract: Context: The effect of the anti-inflammatory and immunomodulatory actions of vitamin D on the duration of partial clinical remission (PR) in youth with type 1 diabetes (T1D) is unclear. Objective: This work aimed to determine the effect of adjunctive ergocalciferol on residual β-cell function (RBCF) and PR in youth with newly diagnosed T1D who were maintained on a standardized insulin treatment protocol. The hypothesis was that ergocalciferol supplementation increases RBCF and prolongs PR. Methods: A 12-month, randomized, double-blind, placebo-controlled trial was conducted of 50 000 IU of ergocalciferol per week for 2 months, and then once every 2 weeks for 10 months, vs placebo in 36 individuals aged 10 to 21 years, with T1D of less than 3 months and a stimulated C-peptide (SCP) level greater than or equal to 0.2 nmol/L (≥ 0.6 ng/mL). The ergocalciferol group had 18 randomly assigned participants (10 male/8 female), mean age 13.3 ± 2.8 years, while the control group had 18 participants (14 male/4 female), aged 14.3 ± 2.9 years. Results: The ergocalciferol treatment group had statistically significantly higher serum 25-hydroxyvitamin D at 6 months (P = .01) and 9 months (P = .02) than the placebo group. At 12 months, the ergocalciferol group had a statistically significantly lower serum tumor necrosis factor α (TNF-α) concentration (P = .03). There were no statistically significant differences between the groups at each time point from baseline to 12 months for SCP concentration (P = .08), glycated hemoglobin A1c (HbA1c) (P = .09), insulin dose-adjusted A1c (IDAA1c), or total daily dose of insulin. Temporal trends for rising HbA1c (P = .04) and IDAA1c (P = .02) were statistically significantly blunted in the ergocalciferol group. Conclusion: Ergocalciferol statistically significantly reduced serum TNF-α concentration and the rates of increase both in A1c and IDAA1c, suggesting a protection of RBCF and PR in youth with newly diagnosed T1D.
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/28276
Funding and AcknowledgementsThis work was supported by an investigator-initiated research grant from the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (grant No. 1 R21 DK113353-03, to B.U.N.). The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
These supplementary materials support the following published study: Nwosu BU, Parajuli S, Jasmin G, Fleshman J, Sharma RB, Alonso LC, Lee AF, Barton BA. Ergocalciferol in New-onset Type 1 Diabetes: A Randomized Controlled Trial. J Endocr Soc. 2021 Nov 26;6(1):bvab179. doi: 10.1210/jendso/bvab179. PMID: 34913020; PMCID: PMC8668202. View article on publishers' site