Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01864057
The ClinicalTrials.gov registry entry for NCT01864057 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which thiamine hydrochloride 100 mg is the first listed.
NCT01864057 reports 0 study locations.
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
Explore more on PlainTrial
Related
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, the data changelog, or report a data error.