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NCT04629534 · ClinicalTrials.gov registry record · Phase 4
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study
A Phase 4 study, sponsored by Medical University of South Carolina.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT04629534: Clinical Trial Phase 4 study, sponsored by Medical University of South Carolina.
NCT04629534 is a Phase 4 study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04629534, a Phase 4 study, was terminated before completion, sponsored by Medical University of South Carolina.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D status in breastfed, preterm infants (\<35 weeks), there will be an increase infant 25(OH)D status at 1,2, and 3 months of age.
Primary Outcome
Number of infants with 25(OH)D levels \> 20 ng/mL
Interventions
- DRUG Cholecalciferol
- DRUG High dose Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2022-04-01 |
| Phase | Phase 4 |
Why NCT04629534 stopped before completion
NCT04629534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Cholecalciferol is the first listed.
NCT04629534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04629534 about?
NCT04629534 is a clinical study titled "Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study". The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D...
What is the current status of trial NCT04629534?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2021-05-06. Estimated completion is 2022-04-01.
What interventions are being tested in trial NCT04629534?
The interventions under investigation include: Cholecalciferol (DRUG), High dose Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT04629534?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04629534's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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