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 Title of Study: “Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs: Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 30, 2020
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.
- Drug: Thiamine 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
Arms, Groups and Cohorts
- Experimental: Low dose
- Low dose of thiamin supplementation
- Experimental: High dose
- High dose of thiamin supplementation
- Placebo Comparator: Placebo
- placebo supplementation
Clinical Trial Outcome Measures
- Change in thiamin pyrophosphate effect
- Time Frame: 4 weeks
- Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation
Participating in This Clinical Trial
- 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 Eligibility: All
Minimum Age: 1 Month
Maximum Age: 15 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Mahidol University
- Provider of Information About this Clinical Study
- Principal Investigator: Narumon Densupsoontorn, Associate Professor – Mahidol University
- Overall Official(s)
- Narumon Densupsoontorn, MD, Principal Investigator, Siriraj Hospital
- Overall Contact(s)
- Narumon Densupsoontorn, MD, 662 4197000, firstname.lastname@example.org
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