Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05390086
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2022-05-16
Brief Title:
Further Development and Assessment of Tools to Measure Risk Factors for and Treatment of Thiamine Deficiency Disorders
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Further Development and Assessment of Tools to Measure Risk Factors for and Treatment of Thiamine Deficiency Disorders a Comparison of Rural and Urban Contexts in Lao PDR
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
The studys 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 different contexts in Lao PDR specifically urban Vientiane and rural Luang Prabang Clinical observers based at the participating hospitals within each countryregion will record the presenting signs and symptoms of all children within the target age range 21 days - 18 months over a one month period For children who meet the eligibility criteria and informed consent is obtained information will be collected on duration of hospital stay received medical treatments final physician diagnosis and risk factor questionnaires see below This data will be used to determine the sensitivity and specificity of the practical TRD case definition tool to accurately identify children who would benefit from thiamine treatment and reduce treatment uncertainties
The secondary objective is to explore risk factors associated with TDDTRD among infants and young children and their mothers This will help to identify potential metrics that could be included in a community risk factor screening tool to identify population groups at risk of thiamine deficiency so appropriate preventive interventions can be implemented Data will be collected on diet and household risk factors for thiamine deficiency including infant and young child feeding practices maternal dietary practices maternal health status and household socioeconomic status and food security
The secondary objective is to explore risk factors associated with TDDTRD among infants and young children and their mothers This will help to identify potential metrics that could be included in a community risk factor screening tool to identify population groups at risk of thiamine deficiency so appropriate preventive interventions can be implemented Data will be collected on diet and household risk factors for thiamine deficiency including infant and young child feeding practices maternal dietary practices maternal health status and household socioeconomic status and food security
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None