A Phase 4 interventional study of Thiamine 1 and Non-thiamine in Obesity, Child and Thiamine Deficiency, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 7 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Mahidol University · Phase 4, Interventional, and Screening
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.
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.
Exclusion Criteria:
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
no symptoms and signs of thiamine deficiency
Other: Non-thiamine
presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
Drug: Thiamine 2
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
no symptoms and signs of thiamine deficiency
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
abnormal thiamin pyrophosphate effect
Thiamin pyrophosphate effect will be measured by a blood test
Time frame: 7 days
consumption of thiaminase-containing foods and thiamin antagonist-containing foods
Food diary and food frequency questionaire will be required to evaluate food consumption
Time frame: 7 days
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Mahidol University