Thiamin Deficiency in Obese Thai Children

Phase 4

Completed

• Conditions: Thiamine Deficiency; Obesity; Child
• Interventions: Drug: Thiamine 1; Drug: Thiamine 2; Other: Non-thiamine

• Registration Number: NCT02464865
• Lead Sponsor: Mahidol University

Brief Summary

This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.

Detailed Description

This study is a cross-sectional study. The objectives of the study are to determine the prevalence of thiamin deficiency in obese Thai children and to assess the associations of dietary factors and thiamin deficiency.

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Study Start: 2015-08
• Primary Completion: 2018-07
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• obese : weight for height > median + 3 standard deviations
• simple obesity

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Exclusion Criteria

• pathological obesity
• chronic diseases e.g. cerebral palsy, metabolic disease, etc.
• diseases of red blood cells
• on medication e.g. steroid, multivitamins, thiamine-containing vitamins, diuretic drugs
• hemodialysis or peritoneal dialysis
• bariatric surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thiamine 1	Thiamine 1	presence of severe symptoms and signs of thiamine deficiency: heart failure, convulsion, coma, loss of ankle and knee jerks with muscular wasting and paralysis (typically symmetrical foot- and wrist-drop)
Thiamine 2	Thiamine 2	presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
Non-thiamine	Non-thiamine	no symptoms and signs of thiamine deficiency

Primary Outcome Measures

Name	Time	Method
abnormal thiamin pyrophosphate effect	7 days	Thiamin pyrophosphate effect will be measured by a blood test

Secondary Outcome Measures

Name	Time	Method
consumption of thiaminase-containing foods and thiamin antagonist-containing foods	7 days	Food diary and food frequency questionaire will be required to evaluate food consumption

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand