Clinical trial NCT03989700: Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs
Official title: Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Heart Diseases
Keywords: Diuretic drugs
Thiamin deficiency
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Enroll children with heart disease receiving diuretic drugs
2. Evaluate thiamin status by measuring thiamin pyrophosphate effect, cardiac function by echocardiography
3. Randomize subjects into 3 arms: 2 groups receive different dosages of thiamin supplementation and 1 group receives placebo for 4 weeks
4. After 4 weeks, thiamin status and echocardiography are evaluated.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in thiamin pyrophosphate effect
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital
name: Narumon Densupsoontorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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