Effect of Vitamin D on the Honeymoon Period in Children and Adolescents With Type 1 Diabetes

This study is currently recruiting participants.
Verified January 2014 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Kathryn Stephens, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01724190
First received: November 7, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Drug: Vitamin D
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Effect of Vitamin D Supplementation on Rate of Partial Clinical Remission in Children and Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • IDAA1c [ Time Frame: 9 months disease duration ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • fasting c-peptide [ Time Frame: diagnosis and 9 months disease duration ] [ Designated as safety issue: No ]
    Endogenous insulin production and secretion will be determined by measuring changes in fasting c-peptide levels at diagnosis and at 9 months of disease duration.

  • high sensitivity c-reactive protein (hsCRP) [ Time Frame: diagnosis and 9 months disease duration ] [ Designated as safety issue: No ]
    Changes in systemic inflammation will be determined by measuring hsCRP at diagnosis and at 9 months of disease duration.

  • interleukin-6 (IL-6) [ Time Frame: diagnosis and 9 months disease duration ] [ Designated as safety issue: No ]
    Changes in systemic inflammation will be determined by measuring IL-6 at diagnosis and 9 months of disease duration.

  • tumor necrosis factor-alpha (TNF-alpha) [ Time Frame: diagnosis and 9 months disease duration ] [ Designated as safety issue: No ]
    Changes in systemic inflammation will be determined by measuring TNF-alpha at diagnosis and 9 months of disease duration.

  • 25-(OD)D [ Time Frame: diagnosis and 9 months disease duration ] [ Designated as safety issue: No ]
    Comparisons will be made between 25-(OH)D status at diagnosis and 9 months disease duration with IDAA1c at 3, 6, and 9 months to assess the relationship between 25-(OD)D and our primary outcome of partial clinical remission.


Estimated Enrollment: 54
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.
Drug: Vitamin D
Other Name: Cholecalciferol
Placebo Comparator: Placebo
Subjects will receive a placebo solution daily over the course of 9 months.
Drug: Placebo

Detailed Description:

Type 1 diabetes is an autoimmune disease characterized by destruction of the insulin secreting beta-cells of the pancreas. There is evidence that Vitamin D may play a role in the initial risk of development of autoimmune disease, including type 1 diabetes. However, Vitamin D may also play a role the natural progression of type 1 diabetes by altering innate insulin secretion and sensitivity and by influencing systemic inflammation, directly at the level of the beta-cell. Studies have shown that Vitamin D insufficiency or deficiency is frequently reported in children and adolescents with type 1 diabetes. A majority of newly diagnosed patients with type 1 diabetes enter a period of partial clinical remission, characterized by low or even absent insulin requirements, also known as a honeymoon period. This honeymoon period is associated with improved metabolic control, near normal insulin sensitivity, and recovery of beta-cell function leading to preservation of endogenous insulin secretion. We hypothesize that supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes will halt the destructive process within the beta cell and improve beta-cell function by increasing endogenous insulin secretion and decreasing systemic inflammation, thereby increasing the rate of partial clinical remission.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children and adolescents ages 4-18 years old with newly diagnosed type 1 diabetes.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724190

Contacts
Contact: Kathryn J Stephens, MD 614-722-4104 kathryn.stephens@nationwidechildrens.org
Contact: Robert P Hoffman, MD 614-722-4425 robert.hoffman@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Kathryn J Stephens, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Kathryn J Stephens, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Kathryn Stephens, Endocrinology Fellow, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01724190     History of Changes
Other Study ID Numbers: 285412
Study First Received: November 7, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Type 1 Diabetes
Vitamin D
Clinical Remission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 14, 2014