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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  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:


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
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: 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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 21, 2014