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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yanbin Dong, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01583621
First received: April 3, 2012
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Cardiovascular phenotypes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 96
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   13 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583621

Locations
United States, Georgia
Georgia Prevention Institute
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Yanbin Dong, MD, PhD Georgia Regents University
  More Information

No publications provided

Responsible Party: Yanbin Dong, Professor, Department of Pediatrics, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01583621     History of Changes
Other Study ID Numbers: pro#00000051
Study First Received: April 3, 2012
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Overweight
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Cholecalciferol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014