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

Conditions

Vitamin D Deficiency

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.

Li Chen, Yanbin Dong, Jigar Bhagatwala, Anas Raed, Ying Huang et al. (6 authors)

Circulation2018-03-20

10.1161/circ.137.suppl_1.p012

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

Jigar Bhagatwala, Haidong Zhu, Samip Parikh, De-Huang Guo, Ishita Kotak et al. (15 authors)

BMC Obesity2015-07-0325 citations

10.1186/s40608-015-0056-2

Abstract MP20: Vitamin D Supplementation Increases Global DNA Methylation in Overweight and Obese African Americans with Vitamin D Deficiency

Haidong Zhu, Ying Huang, Jigar Bhagatwala, Samip Parikh, Robyn Havens et al. (7 authors)

Circulation2014-03-25

10.1161/circ.129.suppl_1.mp20

Interventions

DIETARY_SUPPLEMENTCholecalciferol

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

13 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed