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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Cholecalciferol

• Registration Number: NCT01583621
• Lead Sponsor: Augusta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Primary Completion: 2012-11
• Study Completion: 2015-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. African-Americans (blacks)
2. Age 13-45
3. Overweight/obese (BMI ≥ 85th percentile for their age and gender for age 13-17 and BMI ≥ 25 kg/m2 for age 18-45)
4. Relatively healthy (no medical history of any heart, lung, endocrine or malignant disorder)
5. Non pregnant
6. Not on any medication or vitamin supplements that can influence the study outcomes
7. Serum 25 hydroxy Vitamin D (25[OH] D) levels ≤ 20 ng/ml (50 nmol/L) at the time of screening

Exclusion Criteria

1. Not meeting any one or more of the above criteria
2. Females who become pregnant/test positive on urine pregnancy test during the screening or any of the testing visits
3. Anyone who is taking any multivitamin supplements that contains vitamin D

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplementation arm 3	Cholecalciferol	cholecalciferol 120000 U/month for 4 months
Supplementation arm 1	Cholecalciferol	cholecalciferol 18000 U/month for 4 months
supplementation arm 2	Cholecalciferol	cholecalciferol 60000 U/month for 4 months

Primary Outcome Measures

Name	Time	Method
Cardiovascular phenotypes	16 weeks	Will be using 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.
Primary outcome 1 dose-responsive effects of vitamin D3 supplementations	16 weeks	To compare the dose-responsive effects of vitamin D3 supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.
Primary Outcome 2 dose-responsive effects of vitamin D3 supplementations	16 weeks	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.

Trial Locations

Locations (1)

Georgia Prevention Institute; 🇺🇸 Augusta, Georgia, United States