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The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM

This study is not yet open for participant recruitment.
Verified October 2012 by Children's Hospital Los Angeles
Sponsor:
Information provided by (Responsible Party):
Roshanak Monzavi MD, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01697228
First received: September 28, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

The investigators are conducting a prospective cross-over study to evaluate the effects of vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to see a significant improvement in glycemic control and a reduction of serum pro-inflammatory markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who are treated with vitamin D.


Condition Intervention
Type 1 Diabetes
Vitamin D Deficiency/Insufficiency
 Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months)


Secondary Outcome Measures:
  • Pro-inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods

  • Vitamin D level and proinflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α

  • Vitamin D levels on insulin requirements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Correlation between the change of vitamin D levels on insulin requirements

  • Vitamin D level and HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Correlation between the change in vitamin D level in the blood and change in HbA1c

  • Baseline differences between vitamin D deficient & sufficient subjects [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Comparison of baseline differences between vitamin D deficient/insufficient subjects and vitamin D sufficient subjects (including pro-inflammatory markers, HbA1c and total daily insulin requirements


Estimated Enrollment: 26
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Immediate treatment group
This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.
 Dietary Supplement: Vitamin D
Delayed treatment group
This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.
 Dietary Supplement: Vitamin D

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 13 to 21 years of age, with at least Tanner stage 4 sexual maturity for males or post-menarchal females, and T1DM for at least 1 year. To ensure that inclusion criteria for sexual maturity are met, a physical exam for research purposes will be performed.
  2. HbA1c between 7 to 9%
  3. Adequate renal function (serum creatinine < 1.5 mg/dL in males and < 1.2 mg/dL in females) and adequate liver function (AST and ALT < 2.5 times the upper limit of normal)
  4. Vitamin D insufficiency or deficiency (25-OH vit D level < 30ng/mL) which will be determined on initial screening labs after consenting subjects.

Exclusion Criteria:

  1. Less than 13 or greater than 21 years of age
  2. Less than Tanner stage 4 sexual maturity for males or pre-menarche
  3. HbA1c less than 7% or greater than 9%
  4. T1DM for less than 1 year
  5. Vitamin D sufficient (25-OH vit D level > 30 ng/mL)
  6. Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs
  7. Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids
  8. Inadequate renal function (serum creatinine > 1.5mg/dL in males and > 1.2mg/dL in females) or inadequate liver function (AST and ALT > 2.5 times the upper limit of normal)
  9. Evidence of malabsorption or short gut.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697228

Contacts
Contact: Erin Shih, D.O. (323) 361-8705 eshih@chla.usc.edu

Locations
United States, California
Children's Hospital Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Erin Shih, D.O.     323-361-8705     eshih@chla.usc.edu    
Sub-Investigator: Erin Shih, D.O.            
Principal Investigator: Roshanak Monzavi, M.D.            
Sub-Investigator: Steven Mittelman, M.D., Ph.D.            
Sub-Investigator: Pisit Pitukcheewanont, M.D.            
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
Principal Investigator: Roshanak Monzavi, M.D. Children's Hospital Los Angeles
  More Information

No publications provided

Responsible Party: Roshanak Monzavi MD, Assistant Professor, Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01697228     History of Changes
Other Study ID Numbers: 11-00352
Study First Received: September 28, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Los Angeles:
Diabetes
Vitamin D
Proinflammatory markers

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

ClinicalTrials.gov processed this record on May 19, 2013