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NCT01909115 · ClinicalTrials.gov registry record · Phase 1

Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease

A Phase 1 study, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
98
Enrollment target

NCT01909115 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 98 participants.

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The verdict

NCT01909115, a Phase 1 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
98 participants
Enrollment target

Study Summary

Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vitamin D deficiency, but none has been completely successful. The investigators are comparing two different doses of vitamin D to determine which one is more effective at correcting and maintaining normal blood levels of vitamin D. The investigators hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be vitamin D replete at the end of 6 months. This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD) and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.

Interventions

  • DRUG 1000 IU of Vitamin D3
  • DRUG 4000 IU of Vitamin D3

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2013-09
Est. Completion 2014-09-26
Phase Phase 1

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT01909115

The ClinicalTrials.gov registry entry for NCT01909115 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 1000 IU of Vitamin D3 is the first listed.

NCT01909115 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01909115 about?

NCT01909115 is a clinical study titled "Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease". Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vi...

What is the current status of trial NCT01909115?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2013-09. Estimated completion is 2014-09-26.

What interventions are being tested in trial NCT01909115?

The interventions under investigation include: 1000 IU of Vitamin D3 (DRUG), 4000 IU of Vitamin D3 (DRUG).

Who is sponsoring clinical trial NCT01909115?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.