Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs: Randomized Controlled Trial

Conditions
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Heart Diseases

Intervention / Treatment
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* Drug: Thiamine Mononitrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 1 month old to 15 years old diagnosed as heart disease Receiving diuretic drugs at least 1 month 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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enroll children with heart disease receiving diuretic drugs Evaluate thiamin status by measuring thiamin pyrophosphate effect, cardiac function by echocardiography Randomize subjects into 3 arms: 2 groups receive different dosages of thiamin supplementation and 1 group receives placebo for 4 weeks After 4 weeks, thiamin status and echocardiography are evaluated.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>Low dose of thiamin supplementation | Drug: Thiamine Mononitrate<br>* Low dose group: thaimine mononitrate 25 mg/day per oral daily for 4 weeks High dose group: thaimine mononitrate 50 mg/day per oral daily for 4 weeks Placebo group: placebo 25 mg/day per oral daily for 4 weeks<br>* Other names: Vitamin B1;|
| Experimental: High dose<br>High dose of thiamin supplementation | Drug: Thiamine Mononitrate<br>* Low dose group: thaimine mononitrate 25 mg/day per oral daily for 4 weeks High dose group: thaimine mononitrate 50 mg/day per oral daily for 4 weeks Placebo group: placebo 25 mg/day per oral daily for 4 weeks<br>* Other names: Vitamin B1;|
| Placebo Comparator: Placebo<br>placebo supplementation | Drug: Thiamine Mononitrate<br>* Low dose group: thaimine mononitrate 25 mg/day per oral daily for 4 weeks High dose group: thaimine mononitrate 50 mg/day per oral daily for 4 weeks Placebo group: placebo 25 mg/day per oral daily for 4 weeks<br>* Other names: Vitamin B1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in thiamin pyrophosphate effect | Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diuretic drugs, Thiamin deficiency