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Relative Efficacy of Vitamins D2 and D3 in Adult Humans

NCT ID: NCT01139840

Last Updated: 2011-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.

Detailed Description

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Conditions

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Healthy

Keywords

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vitamin D2 vitamin D3 ergocalciferol cholecalciferol vitamin D status To determine relative potency of vitamins D2 and D3 under conditions of continuous administration To determine change in vitamin D content of subcutaneous fat after 12 weeks' administration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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vitamin D2

Group Type ACTIVE_COMPARATOR

vitamin D2

Intervention Type DIETARY_SUPPLEMENT

Study Supplement

vitamin D3

Group Type ACTIVE_COMPARATOR

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Study Supplement

Interventions

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vitamin D2

Study Supplement

Intervention Type DIETARY_SUPPLEMENT

vitamin D3

Study Supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* willingness to withhold supplement use for duration of study
* willingness to avoid sun exposure for duration of study

Exclusion Criteria

* vitamin D supplement use
* conditions that affect vitamin D metabolism by the body
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Future Foundation

UNKNOWN

Sponsor Role collaborator

BTR Group

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert P Heaney, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.

Reference Type DERIVED
PMID: 21177785 (View on PubMed)

Other Identifiers

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09-15612

Identifier Type: -

Identifier Source: org_study_id