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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03626337
Other study ID # 1329444
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 17, 2019
Est. completion date February 25, 2021

Study information

Verified date August 2022
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A hospital- and community-based study in Luang Prabang, Lao PDR, which will include a group of hospitalized children 21 days to <18 months of age who are diagnosed with symptoms compatible with thiamine deficiency disorder (TDD). Based on the infants' response to thiamine administration, children will be defined as either thiamine responsive disorder (TRD) cases or non-responders. A community-based comparison group of infants in the same age range will be included in the study to serve as a control group for identification of potential risk factors.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Thiamine 100 MG/ML
100 mg thiamine provided as intramuscular injection

Locations

Country Name City State
Lao People's Democratic Republic Lao Friends Hospital for Children Luang Prabang

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis Lao Tropical and Public Health Institute

Country where clinical trial is conducted

Lao People's Democratic Republic, 

References & Publications (2)

Hess SY, Smith TJ, Fischer PR, Trehan I, Hiffler L, Arnold CD, Sitthideth D, Tancredi DJ, Schick MA, Yeh J, Stein-Wexler R, McBeth CN, Tan X, Nhiacha K, Kounnavong S. Establishing a case definition of thiamine responsive disorders among infants and young children in Lao PDR: protocol for a prospective cohort study. BMJ Open. 2020 Feb 13;10(2):e036539. doi: 10.1136/bmjopen-2019-036539. — View Citation

Smith TJ, Tan X, Arnold CD, Sitthideth D, Kounnavong S, Hess SY. Traditional prenatal and postpartum food restrictions among women in northern Lao PDR. Matern Child Nutr. 2022 Jan;18(1):e13273. doi: 10.1111/mcn.13273. Epub 2021 Sep 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Thiamine Responsive Disorder (TRD) Diagnosis of TRD will be determined based on improvements of initially abnormal physical findings such as hepatomegaly, heart rate, and respiratory rate, and resolution of echocardiographic findings of enlarged and poorly functioning ventricles 48-72 hours
Secondary Biomarkers of whole blood thiamine diphosphate (ThDP) and erythrocyte transketolase activity coefficient (ETKac) Associations between ThDP and ETKac with TRD will be determined and appropriate cut-offs of these biomarkers suggesting TRD will be proposed Baseline
Secondary Hemoglobin and biomarkers of other micronutrients (ferritin, transferrin receptor, retinol binding protein, erythrocyte glutathione reductase activation coefficient (EGRAC)), and inflammation (CRP, AGP) Nutrition and health status will be assessed to explore potential risk factors for TRD Baseline
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