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NCT01268176 · ClinicalTrials.gov registry record · Phase 1

The Effect of a Meal on Vitamin D Absorption

A Phase 1 study, sponsored by Tufts University.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target

NCT01268176 is a Phase 1 study that has completed, run by Tufts University. The registered enrollment target is 62 participants.

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The verdict

NCT01268176, a Phase 1 study, has completed, sponsored by Tufts University.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target

Study Summary

This study seeks to determine if vitamin D3 absorption in healthy adults will be enhanced in the presence of a meal and if the enhancement will be greater when the meal is low as opposed to high in fat content. The enhancement will result from increased vitamin D absorption. The investigators will test this hypothesis by pursuing the following aims in a 3-mo trial in which up to 70 healthy men and women will be randomized to one of the following meal conditions under which they will take a monthly oral dose of 50,000 IU of vitamin D3: no meal (fasting), a low fat meal, or a high fat meal. The Primary Aim is to identify the meal condition (fasting, low-fat, or high-fat meal) under which the 25OHD3 response to supplemental vitamin D3 is greatest and most consistent. The Secondary Aim is to determine whether vitamin D3 absorption is affected by the meal condition and to determine whether the absorption of vitamin D3 predicts the longer-term 25OHD3 response to supplementation.

Interventions

  • DIETARY_SUPPLEMENT cholecalciferol

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2010-12
Est. Completion 2012-06
Phase Phase 1

Sponsor

Tufts University

163 total trials

What the Registry Record Tells You About NCT01268176

The ClinicalTrials.gov registry entry for NCT01268176 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts University, which has 163 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which cholecalciferol is the first listed.

NCT01268176 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01268176 about?

NCT01268176 is a clinical study titled "The Effect of a Meal on Vitamin D Absorption". This study seeks to determine if vitamin D3 absorption in healthy adults will be enhanced in the presence of a meal and if the enhancement will be greater when the meal is low as opposed to high in fat content. The enhancement will result from increased vitamin D absorption. The investigators will t...

What is the current status of trial NCT01268176?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2010-12. Estimated completion is 2012-06.

What interventions are being tested in trial NCT01268176?

The interventions under investigation include: cholecalciferol (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01268176?

This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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