Division of Pediatric Endocrinology, Department of Pediatrics; Department of Population and Quantitative Health Sciences
Endocrine System Diseases | Endocrinology | Endocrinology, Diabetes, and Metabolism | Nutritional and Metabolic Diseases | Pediatrics
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.
type 1 diabetes, ergocalciferol, partial clinical remission, pediatrics, C-peptide
Rights and Permissions
© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 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. For commercial re-use, please contact email@example.com.
DOI of Published Version
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 publisher's site
Journal of the Endocrine Society
Supplementary materials for this manuscript, including the 2021 Investigational Study Protocol, are available in UMass Chan Medical School’s institutional repository, eScholarship@UMassChan, at https://doi.org/10.13028/4t76-4325.
Nwosu BU, Parajuli S, Jasmin G, Fleshman J, Sharma RB, Alonso LC, Lee AF, Barton BA. (2021). Ergocalciferol in New-onset Type 1 Diabetes: A Randomized Controlled Trial. Open Access Publications by UMass Chan Authors. https://doi.org/10.1210/jendso/bvab179. Retrieved from https://escholarship.umassmed.edu/oapubs/4981
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.