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

November 7, 2012
January 27, 2014
November 2012
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01724190 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Type 1 Diabetes
  • Drug: Vitamin D
    Other Name: Cholecalciferol
  • Drug: Placebo
  • Active Comparator: Vitamin D
    Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.
    Intervention: Drug: Vitamin D
  • Placebo Comparator: Placebo
    Subjects will receive a placebo solution daily over the course of 9 months.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
4 Years to 18 Years
No
Contact: Kathryn J Stephens, MD 614-722-4104 kathryn.stephens@nationwidechildrens.org
Contact: Robert P Hoffman, MD 614-722-4425 robert.hoffman@nationwidechildrens.org
United States
 
NCT01724190
285412
Yes
Kathryn Stephens, Nationwide Children's Hospital
Nationwide Children's Hospital
Not Provided
Principal Investigator: Kathryn J Stephens, MD Nationwide Children's Hospital
Nationwide Children's Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP