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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697228
• Other study ID #: 11-00352
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: May 4, 2017
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2017
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes
• Vitamin D Deficiency
• Vitamin D Deficiency/Insufficiency

Intervention

Dietary Supplement:
• Vitamin D

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pro-inflammatory markers	Change in pro-inflammatory markers (CRP, IL-6, TNF-a) between treatment and non-treatment periods	6 months
Secondary	Vitamin D level and proinflammatory markers	Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-a	6 months
Secondary	Vitamin D levels on insulin requirements	Correlation between the change of vitamin D levels on insulin requirements	6 months
Secondary	Vitamin D level and HbA1c	Correlation between the change in vitamin D level in the blood and change in HbA1c	6 months
Secondary	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