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

The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Vitamin D Deficiency/Insufficiency
• Intervention / Treatment: Dietary supplement: Vitamin D

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory markers	Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods	6 months
Vitamin D level and proinflammatory markers	Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α	6 months
Vitamin D levels on insulin requirements	Correlation between the change of vitamin D levels on insulin requirements	6 months
Vitamin D level and HbA1c	Correlation between the change in vitamin D level in the blood and change in HbA1c	6 months
Baseline differences between vitamin D deficient & sufficient subjects	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	Baseline

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Roshanak Monzavi, M.D., Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 28, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; Vitamin D; Proinflammatory markers
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Diabetes Mellitus, Type 1; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 11-00352