Overview

This trial is active, not recruiting.

Condition vitamin d deficiency
Treatment cholecalciferol
Sponsor Georgia Regents University
Start date November 2011
End date November 2012
Trial size 96 participants
Trial identifier NCT01583621, pro#00000051

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose health services research
Arm
(No Intervention)
Placebo group
(Experimental)
cholecalciferol 18000 U/month for 4 months
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)
cholecalciferol 60000 U/month for 4 months
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)
cholecalciferol 120000 U/month for 4 months
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).

Primary Outcomes

Measure
Cardiovascular phenotypes
time frame: 16 weeks
Primary outcome 1 dose-responsive effects of vitamin D3 supplementations
time frame: 16 weeks
Primary Outcome 2 dose-responsive effects of vitamin D3 supplementations
time frame: 16 weeks

Eligibility Criteria

Male or female participants from 13 years up to 45 years old.

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

Additional Information

Official title Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
Principal investigator Yanbin Dong, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Georgia Regents University.