Effect of Vitamin D on the Honeymoon Period in Children and Adolescents With Type 1 Diabetes
Effect of Vitamin D Supplementation on Rate of Partial Clinical Remission in Children and Adolescents With Type 1 Diabetes
1 other identifier
interventional
38
1 country
1
Brief Summary
The purpose of this study is to determine if supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter the honeymoon period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 7, 2012
CompletedFirst Posted
Study publicly available on registry
November 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
February 28, 2024
CompletedFebruary 28, 2024
February 1, 2024
1.6 years
November 7, 2012
February 5, 2024
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IDAA1c
Our primary outcome measure will be to determine the rate of partial clinical remission at 9 months of disease duration, which will be assessed by determining insulin dose adjusted hemoglobin A1c (IDAA1c) using the formula (HbA1c% + \[4 x insulin dose u/kg/day\]). A IDAA1c \<9 will be indicative of partial clinical remission.
9 months disease duration
Study Arms (2)
Vitamin D
ACTIVE COMPARATORSubjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.
Placebo
PLACEBO COMPARATORSubjects will receive a placebo solution daily over the course of 9 months.
Interventions
Eligibility Criteria
You may qualify if:
- children and adolescents ages 4-18 years old with newly diagnosed type 1 diabetes.
You may not qualify if:
- age less than 4 years
- pregnant females
- previous or known history of Vitamin D deficiency or insufficiency
- current use of Vitamin D supplementation or multi-vitamin containing \>800 IU daily
- or concurrent development and/or history of other significant systemic illness or non-endocrine autoimmune disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathryn Obrynba
- Organization
- Nationwide Childrens Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn J Stephens, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Endocrinology Fellow
Study Record Dates
First Submitted
November 7, 2012
First Posted
November 9, 2012
Study Start
November 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
February 28, 2024
Results First Posted
February 28, 2024
Record last verified: 2024-02