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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Heart Diseases

Treatments: Drug: Thiamine Mononitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03989700

Si364/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Low dose

Experimental group

Description:

Low dose of thiamin supplementation

Treatment:

Drug: Thiamine Mononitrate

High dose

Experimental group

Description:

High dose of thiamin supplementation

Treatment:

Drug: Thiamine Mononitrate

Placebo

Placebo Comparator group

Description:

placebo supplementation

Treatment:

Drug: Thiamine Mononitrate