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OpenTrials
Completed

NCT Number: NCT01864057

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 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.

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Key information

Conditions

Beriberi Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Thiamine Deficiency Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Svai Chrum Clinic, Mesang District, Prey Veng, Cambodia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mother is at least 18 years of age
  • Infant is between 1 and 12 months of age
  • Cambodian infant is exclusively breast fed
  • Cambodian mother has not taken vitamin supplements within the past month
  • American mother has been taking prenatal vitamins throughout pregnancy and postpartum while breastfeeding
  • Mother and infant do not have an acute illness at the time of enrollment
  • Mother and infant are able to comply with study visits

Exclusion criteria

  • Mother is not able to provide informed consent
  • Cambodian infant has received thiamine injections within the past 2 months

Treatment and study plan

thiamine hydrochloride 100 mg

Drug

Primary outcomes

  1. blood thiamine concentration

    Time frame: 5 days

    blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation

Secondary outcomes

  1. breast milk thiamine concentration

    Time frame: 5 days

    breast milk thiamine concentration after 5 days of maternal thiamine supplementation

Other outcomes

  1. infant thiamine concentration

    Time frame: 5 days

    infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • ARUP Laboratories
  • Eastern Mennonite Missions

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 29, 2013
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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