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

Sponsors

Lead Sponsor: Mahidol University

Source 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.

Overall Status Not yet recruiting
Start Date 2019-07-01
Completion Date 2020-07-31
Primary Completion Date 2020-06-30
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in thiamin pyrophosphate effect 4 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Thiamine Mononitrate

Description: 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

Other Name: Vitamin B1

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

Gender:

All

Minimum Age:

1 Month

Maximum Age:

15 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Narumon Densupsoontorn, MD Principal Investigator Siriraj Hospital
Overall Contact

Last Name: Narumon Densupsoontorn, MD

Phone: 662 4197000

Phone Ext.: 5947

Email: [email protected]

Location
Facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Location Countries

Thailand

Verification Date

2019-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mahidol University

Investigator Full Name: Narumon Densupsoontorn

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Low dose

Type: Experimental

Description: Low dose of thiamin supplementation

Label: High dose

Type: Experimental

Description: High dose of thiamin supplementation

Label: Placebo

Type: Placebo Comparator

Description: placebo supplementation

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention 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.

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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