Supplementary materials for: Ergocalciferol in New-onset Type 1 diabetes: A Randomized Controlled Trial
Authors
Nwosu, Benjamin U.Parajuli, Sadichchha
Jasmin, Gabrielle
Fleshman, Jody
Sharma, Rohit B.
Alonso, Laura C.
Lee, Austin F.
Barton, Bruce A.
UMass Chan Affiliations
Department of Population and Quantitative Health SciencesDivision of Pediatric Endocrinology, Department of Pediatrics
Document Type
DatasetPublication Date
2021-09-15Keywords
type 1 diabetesergocalciferol
partial clinical remission
pediatrics
C-peptide
Endocrine System Diseases
Endocrinology
Endocrinology, Diabetes, and Metabolism
Nutritional and Metabolic Diseases
Pediatrics
Metadata
Show full item recordAbstract
This 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.DOI
10.13028/ps0m-gy55Permanent Link to this Item
http://hdl.handle.net/20.500.14038/28276Funding and Acknowledgements
This 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.Related Resources
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
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Copyright © 2021 The Author(s). This work is licensed under the terms of the Creative Commons Attribution-NonCommercialNoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited.Distribution License
http://creativecommons.org/licenses/by-nc-nd/4.0/ae974a485f413a2113503eed53cd6c53
10.13028/ps0m-gy55
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Except where otherwise noted, this item's license is described as Copyright © 2021 The Author(s). This work is licensed under the terms of the Creative Commons Attribution-NonCommercialNoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited.