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NCT01276587 · ClinicalTrials.gov registry record · Phase 1

Study of Vitamin D in Children With Sickle Cell Disease

A Phase 1 study, sponsored by Gary M Brittenham, MD.

Completed
Registry status
Phase 1
Development phase
4
Enrollment target

NCT01276587: Completed Phase 1 study, sponsored by Gary M Brittenham, MD.

NCT01276587 is a Phase 1 study that has completed, run by Gary M Brittenham, MD. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01276587, a Phase 1 study, has completed, sponsored by Gary M Brittenham, MD.

COMPLETED
Registry status
Phase 1
Development phase
4 participants
Enrollment target

Study Summary

This pilot study aims to answer the question whether monthly oral vitamin D3 supplementation, 100,000 IU, will be safe and effective in raising serum 25-hydroxyvitamin D (form of vitamin D measured in the blood) to levels considered sufficient (30 ng/mL) but well below the threshold for toxicity (150 ng/mL) in children with sickle cell disease. Information from this study will be crucial before we perform a larger clinical trial to determine the effects of vitamin D in reducing respiratory complications in patients with sickle cell disease.

Primary Outcome

Serum 25-hydroxyvitamin D level was measured at 6 months.

Interventions

  • DRUG Vitamin D3

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2011-01
Est. Completion 2011-06
Phase Phase 1
Gary M Brittenham, MD

2 total trials

What the finished NCT01276587 record still lists

NCT01276587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Vitamin D3 is the first listed.

NCT01276587 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01276587 about?

NCT01276587 is a clinical study titled "Study of Vitamin D in Children With Sickle Cell Disease". This pilot study aims to answer the question whether monthly oral vitamin D3 supplementation, 100,000 IU, will be safe and effective in raising serum 25-hydroxyvitamin D (form of vitamin D measured in the blood) to levels considered sufficient (30 ng/mL) but well below the threshold for toxicity (15...

What is the current status of trial NCT01276587?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2011-01. Estimated completion is 2011-06.

What interventions are being tested in trial NCT01276587?

The interventions under investigation include: Vitamin D3 (DRUG).

Who is sponsoring clinical trial NCT01276587?

This trial is sponsored by Gary M Brittenham, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01276587's enrollment target sits among peer trials

4 1995th of 2000 higher than 2 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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Source: ClinicalTrials.gov NCT01276587, the US trial registry maintained by the National Library of Medicine. NCT01276587 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.