Clinical trial NCT01697228: The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM
Official title: The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Vitamin D Deficiency/Insufficiency
Keywords: Diabetes
Vitamin D
Proinflammatory markers
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
Secondary outcomes:
measure: Pro-inflammatory markers
timeFrame: 6 months
measure: Vitamin D level and proinflammatory markers
timeFrame: 6 months
measure: Vitamin D levels on insulin requirements
timeFrame: 6 months
measure: Vitamin D level and HbA1c
timeFrame: 6 months
measure: Baseline differences between vitamin D deficient & sufficient subjects
timeFrame: Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Roshanak Monzavi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: