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NCT01864057 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01864057: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01864057 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01864057, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Thiamine deficiency causes beriberi and is common in parts of rural Cambodia, where it appears to be a leading cause of infant death. The change in maternal and infant thiamine level after administration of thiamine to either Cambodian mothers or their infants is unknown. Normal human breast milk thiamine levels in thiamine-replete mothers are poorly characterized. The aim of this study is to determine if thiamine administered to nursing Cambodian mothers normalizes maternal and infant thiamine levels. Levels will also be obtained in nursing Caucasian mothers residing in the United States.
Primary Outcome
blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation
Interventions
- DRUG thiamine hydrochloride 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01864057 record still lists
NCT01864057 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which thiamine hydrochloride 100 mg is the first listed.
NCT01864057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01864057 about?
NCT01864057 is a clinical study titled "Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants". Thiamine deficiency causes beriberi and is common in parts of rural Cambodia, where it appears to be a leading cause of infant death. The change in maternal and infant thiamine level after administration of thiamine to either Cambodian mothers or their infants is unknown. Normal human breast milk th...
What is the current status of trial NCT01864057?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-01. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01864057?
The interventions under investigation include: thiamine hydrochloride 100 mg (DRUG).
Who is sponsoring clinical trial NCT01864057?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01864057's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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