Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes (PCR)
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|ClinicalTrials.gov Identifier: NCT03046927|
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : June 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Ergocalciferol Other: Placebo||Phase 2 Phase 3|
Prolonging the duration of the partial clinical remission (PCR), or 'honeymoon' phase, of type 1 diabetes (T1D) improves glycemic control and reduces long-term complications. Recent studies suggest the exciting possibility that vitamin D supplementation, a safe and easy-to-implement therapy in children, may lengthen PCR and increase residual beta cell function (RBCF).
However, existing studies employed a suboptimal vitamin D dose or lacked a standardized insulin treatment protocol, precluding solid conclusions and preventing the field from moving forward with translation to clinical practice. This trial's rationale is to securely establish the effect of an adequate dose of vitamin D on PCR and RBCF.
We hypothesize that vitamin D will increase RBCF and prolong PCR. The primary aim is to determine the effect of adjunctive vitamin D on RBCF and PCR in youth with T1D maintained on a standardized insulin protocol. We propose a 12-month randomized, double-blind, placebo-controlled, parallel design trial of ergocalciferol vs. placebo in 40 subjects of 10-21 years with newly-diagnosed T1D. The primary outcome is the change over time in stimulated C-peptide (a measure of RBCF). Secondary outcomes include change over time in insulin-dose-adjusted-hemoglobin-A1c (HbA1c) (IDAA1C; a measure of PCR), HbA1c, and total daily dose of insulin. Mechanistic studies will explore whether beneficial effects of vitamin D are associated with increased GLP-1 levels or decreased inflammatory markers, and whether response to vitamin D is impacted by T1D-risk polymorphisms. If our hypotheses are true, these findings may completely alter the approach to the early management of T1D, with strong emphasis on prolonging the honeymoon phase using a readily available and easily affordable vitamin D while maintaining these patients on a standardized insulin treatment regimen.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||12-month randomized, double-blind, placebo-controlled, parallel design trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Ergocalciferol and placebo will be prepared as identical capsules by Boulevard Pharmaceutical Compounding Center. Randomization will be conducted by the Investigational Drug Services (IDS), UMMS, using a randomization scheme generated by Dr. Barton. Randomization will be 1:1 (ergocalciferol: placebo) and will use a permuted block design with blocking for every 2 or 4 subjects (at random). IDS will maintain blinding information and PI will contact IDS for emergency unblinding.|
|Official Title:||Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
Other Name: Vitamin D
Placebo Comparator: Placebo
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
- Residual beta-cell function (RBCF) [ Time Frame: 12 months ]Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF.
- Glycemic control (HbA1c) [ Time Frame: 12 months ]Exploration of the effect of vitamin D supplementation on glycemic control during PCR by comparing HbA1c values across longitudinal measurements (at 0, 3, 6, 9, and 12 months).
- Glucagon-like peptide-1 (GLP-1) [ Time Frame: 12 months ]Investigation of the effect of vitamin D supplementation on GLP-1 and VDBP during PCR.
- Differences in the duration of PCR in subjects with high-risk SNPs receiving vitamin D vs. placebo [ Time Frame: 12 months ]Determination of whether a single nucleotide polymorphism (SNP)-based T1D genetic risk score influences the effect of vitamin D supplementation on PCR, and the magnitude of RBCF
- Vitamin D Binding Protein (VDBP) [ Time Frame: 12 months ]Investigation of the effect of vitamin D supplementation on VDBP during PCR.
- Duration of Partial Clinical Remission (PCR) [ Time Frame: 12 months ]Investigation of the effect of vitamin D on PCR in the first 12 months after the diagnosis of T1D
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046927
|Contact: Benjamin U Nwosu, M.D.||5083347872||Benjamin.Nwosu@umassmemorial.org|
|Contact: Deepa Patel, MPH||Deepa.Patel@umassmed.edu|
|United States, Massachusetts|
|University of Massachusetts Medical School||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Deepa Patel, MPH Deepa.Patel@umassmed.edu|
|Contact: Antonio Villalobos-Ortiz, MS Antonio.Villalobos-Ortiz@umassmed.edu|
|Principal Investigator:||Benjamin U Nwosu, MD||University of Massachusetts, Worcester|