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

Vitamin D Deficiency Clinical Trial

— D-SUNNY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583621
• Other study ID #: pro#00000051
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: February 8, 2017
• Start date: November 2011
• Est. completion date: August 2015

Study information

• Verified date: February 2017
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Vitamin D Deficiency

Intervention

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).

Locations

Country	Name	City	State
United States	Georgia Prevention Institute	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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