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Trial record 17 of 22 for:    "Beriberi"

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

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ClinicalTrials.gov Identifier: NCT03989700
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Narumon Densupsoontorn, 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.

Condition or disease Intervention/treatment Phase
Heart Diseases Drug: Thiamine Mononitrate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs: Randomized Controlled Trial
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Low dose
Low dose of thiamin supplementation
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
Other Name: Vitamin B1

Experimental: High dose
High dose of thiamin supplementation
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
Other Name: Vitamin B1

Placebo Comparator: Placebo
placebo supplementation
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
Other Name: Vitamin B1




Primary Outcome Measures :
  1. Change in thiamin pyrophosphate effect [ Time Frame: 4 weeks ]
    Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation



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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989700


Contacts
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Contact: Narumon Densupsoontorn, MD 662 4197000 ext 5947 narumon.den@mahidol.ac.th

Locations
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Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Narumon Densupsoontorn, MD Siriraj Hospital

Additional Information:
Publications:

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Responsible Party: Narumon Densupsoontorn, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT03989700     History of Changes
Other Study ID Numbers: Si364/2019
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Narumon Densupsoontorn, Mahidol University:
Diuretic drugs
Thiamin deficiency

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Diuretics
Thiamine
Natriuretic Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances