Thiamin Deficiency in Obese Thai Children

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

Detailed Description
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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.

Official Title
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Thiamin Deficiency in Obese Thai Children

Conditions
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Obesity, Child, Thiamine Deficiency

Intervention / Treatment
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* Drug: Thiamine 1
* Other: Non-thiamine
* Drug: Thiamine 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obese : weight for height > median + 3 standard deviations simple obesity 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thiamine 1<br>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) | Drug: Thiamine 1<br>* If severe symptoms and signs of thiamine deficiency are present, thiamine is prescribed. Intervention 1 : severe symptom (heart failure, convulsion, or coma) : 50 mg thiamin administered very slowly intravenously, followed by a daily intramuscular dose of 10 mg for a week, and finally followed by 3-5 mg of thiamine per day orally for at least 6 weeks<br>|
| Other: Non-thiamine<br>no symptoms and signs of thiamine deficiency | Other: Non-thiamine<br>* no symptoms and signs of thiamine deficiency<br>|
| Experimental: Thiamine 2<br>presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet) | Drug: Thiamine 2<br>* If symptoms and signs of thiamine deficiency are present, thiamine is prescribed. If mild symptom : a daily oral dose of 10 mg thiamin during the first week, followed by 3-5 mg of thiamin per day orally for at least 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abnormal thiamin pyrophosphate effect | Thiamin pyrophosphate effect will be measured by a blood test | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of thiaminase-containing foods and thiamin antagonist-containing foods | Food diary and food frequency questionaire will be required to evaluate food consumption | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thiamine deficiency, obese children, Thai