Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs
- Registration Number
- NCT03989700
- Lead Sponsor
- Mahidol University
- Brief Summary
The purpose of this study is to determine effect of thiamin supplementation on thiamin status by measuring thiamin pyrophosphate effect in children with heart disease receiving diuretic drugs.
- Detailed Description
Children with heart disease receiving diuretic drugs are susceptible to thiamin deficiency due to increase renal loss. Thiamin deficiency causes abnormal cardiac contraction resulting in heart failure.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Children aged 1 month old to 15 years old diagnosed as heart disease
- Receiving diuretic drugs at least 1 month
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Exclusion Criteria
- Receiving thiamin-containing vitamins
- Receiving hemodialysis or peritoneal dialysis
- Having problems of intestinal malabsorption, chronic lung disease, red blood cell abnormality such as thalassemia , abnormal hemoglobin typing, G6PD deficiency
- Receiving thiamin-producing probiotics
- Receiving inotropic drugs
- Severe anemia: Hb < 7 g/dL
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose Thiamine Mononitrate Low dose of thiamin supplementation High dose Thiamine Mononitrate High dose of thiamin supplementation Placebo Thiamine Mononitrate placebo supplementation
- Primary Outcome Measures
Name Time Method Change in thiamin pyrophosphate effect 4 weeks Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Medicine Siriraj Hospital, Mahidol University
🇹ðŸ‡Bangkok, Thailand