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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Cholecalciferol

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Prevention Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo; Placebo group
Experimental: Supplementation arm 1; cholecalciferol 18000 U/month for 4 months	Dietary supplement: Cholecalciferol; 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).
Experimental: supplementation arm 2; cholecalciferol 60000 U/month for 4 months	Dietary supplement: Cholecalciferol; 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).
Experimental: Supplementation arm 3; cholecalciferol 120000 U/month for 4 months	Dietary supplement: Cholecalciferol; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Augusta University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Overweight; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: pro#00000051