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Withdrawn No phase listed Observational Accepts healthy volunteers

Vitamin D Ancillary Study in 5 Populations of African Origin

ClinicalTrials.gov ID: NCT02111902

Public ClinicalTrials.gov record NCT02111902. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Determinants and Consequences of Low Vitamin D in Populations of African Descent

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The availability of data on plasma 25-Hydroxyvitamin D (25(OH)D) concentrations in the last two rounds of the National Health and Nutrition Examination Survey (NHANES) has generated a high level of interest in the consequences of 25(OH)D deficiency and in particular its potential impact on black Americans. Fundamental new questions about the biology of vitamin D have now come to the fore. Are low 25(OH)D-intact parathyroid hormone (iPTH) levels a physiologic "abnormality" in African Americans or does the 25(OH)D-iPTH system have sufficient plasticity to adapt to low sunlight exposure? Could the low 25(OH)D levels which result from the "gene- environment discordance" observed in dark skinned populations in the US be a risk factor for metabolic disorders? Ultimately, the public health community and regulatory bodies must offer recommendations for optimal levels and supplementation. The investigators propose to utilize cohorts from an ongoing NIH-funded study designed to identify determinants of weight change and cardiovascular disease risk in five Afro-origin populations \[Modeling the Epidemiologic Transition Study (METS)\] to examine these questions. The five METS countries include Ghana, Seychelles, South Africa, Jamaica and the US; the five populations differ greatly in terms of sun exposure and dietary intakes. In addition to the extensive energy expenditure, dietary intake and obesity-related metabolic markers being measured in METS, the investigators propose to assess plasma 25(OH)D, iPTH, serum and urinary calcium, plasma markers of bone resorption and formation, and quantitative ultrasound of the calcaneus. The associations of adiposity, weight change, cardiovascular disease (CVD) risk factors such as blood pressure and insulin, and bone strength with 25(OH)D and iPTH will be assessed. The proposed study will provide a comprehensive assessment of the distribution and determinants of 25(OH)D-iPTH and related physiologic measures across a wide range of latitude and lifestyles. These data should contribute substantially to the understanding of the "normal" range within which these hormones function and their significance in Afro- origin populations.

Study identification

NCT ID
NCT02111902
Recruitment status
Withdrawn
Study type
Observational
Phase
Not listed
Lead sponsor
Loyola University
Other
Enrollment
Not listed

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
25 Years to 44 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2011
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011
Last update posted
Aug 29, 2017

2011

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Department of Public Health Sciences; Loyola University Chicago Maywood Illinois 60153

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02111902, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 29, 2017 · Synced Sep 2, 2026

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