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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03989700

Enrollment

Registered

2019-06-18

Start date

2019-07-01

Completion date

2020-07-31

Last updated

2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Diuretic drugs, Thiamin deficiency

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.

Interventions

DRUGThiamine Mononitrate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender

ALL

Age

1 Months to 15 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in thiamin pyrophosphate effect	4 weeks	Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation

Countries

Thailand

Contacts

Primary ContactNarumon Densupsoontorn, MD

narumon.den@mahidol.ac.th662 4197000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026