Vitamin D and Vascular Health in Children

Obesity Clinical Trial

Official title: Vitamin D and Vascular Function in Obese Children

Status Completed

Clinical Trial 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 metabolic syndrome risk profile.

Clinical Trial 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 vitamin D3 supplementation in improving vascular endothelial function, arterial stiffness, insulin sensitivity, and metabolic syndrome risk status; and to assess whether these effects are dose-dependent. As a secondary objective, we will examine the vitamin D supplementation-induced effect on adipokines and inflammatory markers relevant to CVD risk. In a double-masked, controlled trial, we will randomize 252 eligible children to receive either 600 IU (conventional supplementation), or 1000 IU or 2000 IU (enhanced supplementation) of vitamin D3 daily for 6 months.

In terms of reporting of results, the following pre-specified outcomes are included in the primary manuscript (PubMed PMID:31950134 -- see Reference section for citation details)

1. Waist Circumference

2. Serum High Density Lipoprotein (HDL) Cholesterol

3. Serum Triglycerides

4. Inflammatory markers (Plasma TNF-alpha, high-sensitivity C-reactive protein, and IL-6)

5. Adiopkines (Plasma Leptin and Adiponectin)

Plasma nitric oxide metabolites were not measured. ;

Related Conditions & MeSH terms

• Obesity
• Vitamin D Deficiency

• NCT number: NCT01797302
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Completion date: August 13, 2018