Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
D-SUNNY
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 3, 2012
CompletedFirst Posted
Study publicly available on registry
April 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFebruary 9, 2017
February 1, 2017
1 year
April 3, 2012
February 8, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Cardiovascular phenotypes
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.
16 weeks
Primary outcome 1 dose-responsive effects of vitamin D3 supplementations
To compare the dose-responsive effects of vitamin D3 supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.
16 weeks
Primary Outcome 2 dose-responsive effects of vitamin D3 supplementations
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.
16 weeks
Study Arms (4)
Placebo
NO INTERVENTIONPlacebo group
Supplementation arm 1
EXPERIMENTALcholecalciferol 18000 U/month for 4 months
supplementation arm 2
EXPERIMENTALcholecalciferol 60000 U/month for 4 months
Supplementation arm 3
EXPERIMENTALcholecalciferol 120000 U/month for 4 months
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgia Prevention Institute
Augusta, Georgia, 30912, United States
Related Publications (1)
Bhagatwala J, Zhu H, Parikh SJ, Guo DH, Kotak I, Huang Y, Havens R, Pham M, Afari E, Kim S, Cutler C, Pollock NK, Dong Y, Raed A, Dong Y. Dose and time responses of vitamin D biomarkers to monthly vitamin D3 supplementation in overweight/obese African Americans with suboptimal vitamin d status: a placebo controlled randomized clinical trial. BMC Obes. 2015 Jul 4;2:27. doi: 10.1186/s40608-015-0056-2. eCollection 2015.
PMID: 26217542DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanbin Dong, MD, PhD
Augusta University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Pediatrics
Study Record Dates
First Submitted
April 3, 2012
First Posted
April 24, 2012
Study Start
November 1, 2011
Primary Completion
November 1, 2012
Study Completion
August 1, 2015
Last Updated
February 9, 2017
Record last verified: 2017-02