Back to resultsVitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY) (D-SUNNY)
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional health services research trial for Vitamin D Deficiency
Eligibility Criteria
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
Sites / Locations
- Georgia Prevention Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Placebo
Supplementation arm 1
supplementation arm 2
Supplementation arm 3
Arm Description
Placebo group
cholecalciferol 18000 U/month for 4 months
cholecalciferol 60000 U/month for 4 months
cholecalciferol 120000 U/month for 4 months
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01583621
Brief Title
Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
Acronym
D-SUNNY
Official Title
Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Placebo group
Arm Title
Supplementation arm 1
Arm Type
Experimental
Arm Description
cholecalciferol 18000 U/month for 4 months
Arm Title
supplementation arm 2
Arm Type
Experimental
Arm Description
cholecalciferol 60000 U/month for 4 months
Arm Title
Supplementation arm 3
Arm Type
Experimental
Arm Description
cholecalciferol 120000 U/month for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Intervention Description
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 Outcome Measure Information:
Title
Cardiovascular phenotypes
Description
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.
Time Frame
16 weeks
Title
Primary outcome 1 dose-responsive effects of vitamin D3 supplementations
Description
To compare the dose-responsive effects of vitamin D3 supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.
Time Frame
16 weeks
Title
Primary Outcome 2 dose-responsive effects of vitamin D3 supplementations
Description
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanbin Dong, MD, PhD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Prevention Institute
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26217542
Citation
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.
Results Reference
derived
Learn more about this trial
Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
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