Vitamin D Supplementation in Overweight/Obese African Ame... | NCT01583621

NCT01583621

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	No Intervention	Placebo group
Supplementation arm 1	Experimental	cholecalciferol 18000 U/month for 4 months	Dietary Supplement: Cholecalciferol
supplementation arm 2	Experimental	cholecalciferol 60000 U/month for 4 months	Dietary Supplement: Cholecalciferol
Supplementation arm 3	Experimental	cholecalciferol 120000 U/month for 4 months	Dietary Supplement: Cholecalciferol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Yanbin Dong, MD, PhD	Augusta University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Georgia Prevention Institute		Augusta	Georgia	30912	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26217542	Derived	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.

Condition Browse Module

ID	Term
D014808	Vitamin D Deficiency

Intervention Browse Module