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Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

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ClinicalTrials.gov Identifier: NCT01864057
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Collaborators:
Eastern Mennonite Missions
ARUP Laboratories
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Beriberi Drug: thiamine hydrochloride 100 mg Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants
Study Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Active Comparator: Cambodian mothers
thiamine hydrochloride 100 mg orally daily for 5 days
Drug: thiamine hydrochloride 100 mg
No Intervention: American mothers
Baseline blood and breast milk sample collection



Primary Outcome Measures :
  1. blood thiamine concentration [ Time Frame: 5 days ]
    blood thiamine and thiamine diphosphate concentrations after 5 days of maternal oral thiamine supplementation


Secondary Outcome Measures :
  1. breast milk thiamine concentration [ Time Frame: 5 days ]
    breast milk thiamine concentration after 5 days of maternal thiamine supplementation


Other Outcome Measures:
  1. infant thiamine concentration [ Time Frame: 5 days ]
    infant blood thiamine and thiamine diphosphate concentrations after 5 days of maternal supplementation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864057


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Cambodia
Svai Chrum Clinic
Mesang District, Prey Veng, Cambodia
Sponsors and Collaborators
Mayo Clinic
Eastern Mennonite Missions
ARUP Laboratories
Investigators
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Principal Investigator: Mark Topazian, M.D. Mayo Clinic

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mark Topazian, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01864057     History of Changes
Other Study ID Numbers: MCR 12-004047; NECHR 208
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Keywords provided by Mark Topazian, Mayo Clinic:
thiamine deficiency
Additional relevant MeSH terms:
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Beriberi
Thiamine Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs