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

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Vitamin D Deficiency/Insufficiency
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT01697228
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-28
• Study Start: 2012-10
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-02
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate treatment group	Vitamin D	This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.
Delayed treatment group	Vitamin D	This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6 months	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

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

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States