Status:
COMPLETED
Vitamin D and Vascular Health in Children
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Conditions:
Obesity
Vitamin D Deficiency
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
In this study, we will test the central hypothesis that enhancement of vitamin D status in obese and overweight children will improve their vascular health and their cardiovascular disease (CVD) and m...
Detailed Description
Our primary objective is to determine, in obese and overweight children aged 10 to 18 years with vitamin D deficiency (defined as serum 25-hydroxyvitamin D \<20 ng/mL), the efficacy of enhanced vitami...
Eligibility Criteria
Inclusion
- Eligible subjects will be 10 to 18 years of age;
- obese or overweight (BMI ≥85th %tile);
- otherwise healthy, and
- have a serum 25(OH)D concentration \<20 ng/mL
- Children taking multivitamins should be able to hold off their multivitamins during the course of the study.
Exclusion
- Children will be excluded if they
- (a) have hepatic or renal disease, metabolic rickets, malabsorptive disorders, primary hyperparathyroidism, hyperthyroidism, or other chronic disorders that could affect vitamin D metabolism;
- (b) are receiving treatment with anticonvulsants, systemic glucocorticoids, pharmacologic doses of vitamin D (≥1000 IU of vitamin D2 or D3 daily), antihypertensives, vasoactive drugs, antilipidemics, metformin, antipsychotics, or other oral insulin regulators;
- (c) have cholelithiasis or urolithiasis;
- (d) have type 1 or type 2 diabetes; or
- (e) have a condition or underlying abnormality that could compromise the safety of the subject.
- Post-menarchial girls with a positive pregnancy test at randomization, or subjects found during the screening phase to have hypercalcemia (serum calcium \>10.8 mg/dL) or significant fasting hyperglycemia (fasting blood glucose ≥ 125 mg/dL) will also be excluded.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2018
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01797302
Start Date
August 1 2013
End Date
August 13 2018
Last Update
June 24 2020
Active Locations (1)
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1
Primary Care Center, Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213