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Comparative Effectiveness of Vitamin D and Repletion Strategies

NCT01524874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2012-02-02

No results posted yet for this study

Summary

The importance of vitamin D (VitD) in the prevention and treatment of human health conditions has gained increased attention in recent years. As a result, medical providers of all categories are screening clinical VitD status frequently, yet become challenged with how to best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement is most effective. It has been recognized that to achieve significant effects - serum concentrations \>30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend substantially higher doses than were previously thought sufficient. These higher doses can be easily achieved orally. This clinical trial aims to compare absorption of three available forms of this fat-soluble vitamin, due to the potential differences in absorption of different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily available as supplements, yet these have not been systematically compared. This three-arm, randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol (25-OH)D concentration between the three arms at baseline and after random administration of one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The investigators hypothesize that the three forms of vitD will result in an equivalent increase in serum 25OHD.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

10,000 IU per Day for 12 Weeks

DIETARY_SUPPLEMENT

Vitamin D3

10,000 IU per Day for 12 Weeks

DIETARY_SUPPLEMENT

Vitamin D3

10,000 IU per Day for 12 Weeks

Sponsors & Collaborators

  • Diabetes Action Research and Education Foundation

    collaborator OTHER

  • Bastyr University

    lead OTHER

Principal Investigators

  • Ryan Bradley, ND, MPH · Bastyr University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-09-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01524874 on ClinicalTrials.gov