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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

13 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

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).

Primary outcomes

Cardiovascular phenotypes

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Acronym: D-SUNNY

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2015
First posted: Apr 24, 2012
Registry last updated: Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed