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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: Completed Phase 1 study, sponsored by Tufts University.
NCT01268176 is a Phase 1 study that has completed, run by Tufts University. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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, specifically, to describe and compare changes in serum 25OHD3 concentration across the 3 groups.
Interventions
- DIETARY_SUPPLEMENT cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01268176 record still lists
NCT01268176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which cholecalciferol is the first listed.
NCT01268176 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01268176's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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