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

Phase 3
Conditions
Heart Diseases
Interventions
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
GroupInterventionDescription
Low doseThiamine MononitrateLow dose of thiamin supplementation
High doseThiamine MononitrateHigh dose of thiamin supplementation
PlaceboThiamine Mononitrateplacebo supplementation
Primary Outcome Measures
NameTimeMethod
Change in thiamin pyrophosphate effect4 weeks

Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

🇹🇭

Bangkok, Thailand

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