Status:
COMPLETED
Further Development and Assessment of Tools to Measure Risk Factors for and Treatment of Thiamine Deficiency Disorders
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Lao Tropical and Public Health Institute
Conditions:
Thiamine Deficiency
Eligibility:
All Genders
21-18 years
Brief Summary
Thiamine deficiency, including the most severe form infantile beriberi, is a public health concern across South and Southeast Asia, where monotonous diets rely on thiamine-poor white rice. Food insecu...
Detailed Description
The study's primary objective is to determine the usefulness of a TRD case definition and practical tool in identifying infants and young children that would benefit from thiamine treatment in differe...
Eligibility Criteria
Inclusion
- Infants and young children aged 21 days - \<18 months presenting to the collaborating hospitals and presenting with at least one of the following signs and symptoms consistent with TDD:
- Enlarged liver (liver edge \>2 cm below the right costal margin)
- Edema
- Tachypnea (respiratory rate \>60/min for 3-8 weeks; \>50/min for 2-11 months; \>40/min for 12-18 months)
- Tachycardia (heart rate \>160/min for \<12 months; \>120/min for 12-18 months)
- Oxygen saturation \<92%
- Difficulty breathing (chest indrawing or nasal flaring)
- Refusal to breastfeed or of infant formula or food for \>24 hours
- Repetitive or recurrent vomiting with no obvious other cause (\>3 times in past 24 hours)
- Persistent crying not relieved by soothing or feeding with no obvious other cause
- Hoarse voice/cry or loss of voice
- Nystagmus or other unusual eye movements
- Muscle twitching
- Loss of consciousness
- Convulsion
- Opisthotonos/abnormal posturing
- Acute/flaccid paralysis
Exclusion
- Infants and young children who do not meet any of the TDD-like signs and symptoms will not be eligible for study participation.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05390086
Start Date
June 15 2022
End Date
August 26 2022
Last Update
April 23 2025
Active Locations (2)
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1
Lao Friends Hospital for Children
Luang Prabang, Laos
2
Children's Hospital
Vientiane, Laos