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A New Paradigm for Vitamin D Sufficiency

NCT02969850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2021-10-22

No results posted yet for this study

Summary

Although the African-American (AA) population tends to have lower serum 25(OH)D levels compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans are harmful. In fact, skeletal health is superior in AA. It is clear that total serum 25(OH)D concentrations do not reflect the same risk/benefit ratio in AA compared to white women and is, therefore, an inappropriate biomarker in this population.

The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The investigators propose a six month randomized double blinded study.

Conditions

  • New Biomarkers for Measuring Vitamin D Level

Interventions

DIETARY_SUPPLEMENT

Vitamin D Supplementation

Subjects in this group will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level.

OTHER

Placebo

Subjects in this group will receive a placebo.

DIETARY_SUPPLEMENT

Calcium

If dietary calcium intake is insufficient in participants of either group, they will be given a calcium supplement in the form of one 600mg pill of CaCO3 to bring them up to an intake of 1200mg/day.

Sponsors & Collaborators

Principal Investigators

  • John Aloia, MD · Winthrop University Hospital

  • Mageda Mikhail, MD · Winthrop University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969850 on ClinicalTrials.gov