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

Children's Hospital Los Angeles

Status: Completed

Conditions: Type 1 Diabetes; Vitamin D Deficiency/Insufficiency

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01697228

11-00352

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Immediate treatment group

Other group

Description:

This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.

Treatment:

Dietary Supplement: Vitamin D

Delayed treatment group

Other group

Description:

This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.

Treatment:

Dietary Supplement: Vitamin D