A Phase 1 interventional study of thiamine hydrochloride 100 mg in Beriberi, sponsored by Mayo Clinic. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-29.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Basic science
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.
In this pharmacokinetic study, thiamine hydrochloride 100 mg will be administered to nursing Cambodian mothers and thiamine levels will be measured in their blood and breast milk before and after supplementation. Their infant's blood thiamine levels will also be measured. A control arm of American breast feeding mothers taking prenatal vitamins will also be enrolled, to allow comparison of maternal blood and breast milk levels between Cambodian and American mothers. Ethics committee approval was obtained in Cambodia (National Ethics Committee for Health Research #208, 2011) and in the United States (Mayo Clinic Rochester IRB #12-004047)for the Cambodian and American portions of the protocol, respectively.
11 studies on the registry are indexed under Beriberi; none are open to participants now.
Browse Beriberi studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
thiamine hydrochloride 100 mg orally daily for 5 days
Drug: thiamine hydrochloride 100 mg
Baseline blood and breast milk sample collection
blood thiamine concentration
blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation
Time frame: 5 days
breast milk thiamine concentration
breast milk thiamine concentration after 5 days of maternal thiamine supplementation
Time frame: 5 days
infant thiamine concentration
infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation
Time frame: 5 days
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thiamine hydrochloride