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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014