NCT01583621

Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 13 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3 supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium. Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3 supplementations on non-invasive vascular measures including pulse wave velocity (PWV), flow-mediated dilation (FMD), carotid arterial compliance (CAC), carotid Intima-Media Thickness (cIMT), and 24-hours Ambulatory Blood Pressure (ABP) monitoring as well as casual BP.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	The participants will be randomized into one of the four groups. Group 0 will be placebo group, group 1 will receive monthly supervised dose of 18,000 IU (equivalent to 600 IU/day), group 2 will receive monthly supervised dose of 60,000 IU(equivalent to 2000 IU/day), and group 3 will receive 120,000 IU (equivalent to 4000 IU/day) vitamin D3 supplementation for 4 months (16 weeks).

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-11-01
• Completion: 2015-08-01
• First posted: 2012-04-24
• Last updated: 2017-02-09

Locations

1 site across 1 country: United States