Vitamin D and Vascular Health in Children
Completed · Not applicable
Conditions studied: Obesity, Vitamin D Deficiency
In brief
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 metabolic syndrome risk profile.
Key facts
- Study ID
- NCT01797302
- Run by
- University of Pittsburgh
- People needed
- 225
- Starts
- 2013-08-01
- Expected to finish
- 2018-08-13
- Last updated by the study team
- 2020-06-24
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Primary Care Center, Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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