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Further Development and Assessment of Tools to Measure Risk Factors for and Treatment of Thiamine Deficiency Disorders

NCT05390086 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2025-04-23

No results posted yet for this study

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 insecurity, food preparation and cooking practices, anti-thiamine compound consumption and culturally determined postpartum food restrictions precipitate thiamine deficiency in these high-risk regions. The risk of thiamine deficiency is highest in the first year of life, especially among exclusively or predominantly breastfed infants of mothers who are thiamine deficient themselves, as thiamine content of breastmilk is related to maternal thiamine status.

However, diagnosis of infantile thiamine deficiency is challenging due to the highly variable, non-specific clinical manifestations, referred to as thiamine deficiency disorders (TDD), that often overlap with other conditions, resulting in misdiagnosis and missed treatment opportunities, which can be fatal or have irreversible consequences. Considering that breastfed infants are at highest risk, a large proportion of infant deaths could be avoided if: 1) infants with TDD were immediately treated with thiamine when medically indicated and, importantly; 2) thiamine deficiency was prevented by improving thiamine status among breastfeeding women. The latter is important given emerging evidence of long-term neurocognitive deficits of severe and even subclinical thiamine deficiency.

In light of these diagnostic uncertainties, it was recognised that a case definition for thiamine responsive disorders (TRD) would help to better identify infants with TDD who would benefit from timely thiamine treatment. This study will test the usefulness of a recently developed case definition for TRD and practical tool in different contexts in Lao PDR where TDD have been reported. Secondly, data on diet, maternal and household risk factors for TDD in different contexts will be used to propose a community risk factor screening tool to better identify populations at risk of thiamine deficiency and help advocate for and guide planning of preventive programmes.

Conditions

  • Thiamine Deficiency

Interventions

OTHER

Standard of care

The study is being implemented among children who are seeking care at collaborating hospitals for signs and symptoms suggestive of TDD. All children will be treated by the hospital physicians following the usual hospital procedures. The study will not interfere in any with the administration of required treatments and interventions.

Sponsors & Collaborators

  • Lao Tropical and Public Health Institute

    collaborator OTHER_GOV

  • University of California, Davis

    lead OTHER

Eligibility

Min Age
21 Days
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2022-08-26
Completion
2022-08-26

Countries

  • Laos

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05390086 on ClinicalTrials.gov