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

NCT03989700 | Unknown Phase 3 DMC

• 1 other identifier: Si364/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

Diuretic drugs; Thiamin deficiency

Outcome Measures

Primary Outcomes (1)

• Change in thiamin pyrophosphate effect

  Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation

  4 weeks

Study Arms (3)

Low dose

EXPERIMENTAL

Low dose of thiamin supplementation

Drug: Thiamine Mononitrate

High dose

EXPERIMENTAL

High dose of thiamin supplementation

Drug: Thiamine Mononitrate

Placebo

PLACEBO COMPARATOR

placebo supplementation

Drug: Thiamine Mononitrate

Interventions

Thiamine Mononitrate DRUG

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

Also known as: Vitamin B1

High dose; Low dose; Placebo

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 month old to 15 years old diagnosed as heart disease
• Receiving diuretic drugs at least 1 month

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (11)

• DiNicolantonio JJ, Niazi AK, Lavie CJ, O'Keefe JH, Ventura HO. Thiamine supplementation for the treatment of heart failure: a review of the literature. Congest Heart Fail. 2013 Jul-Aug;19(4):214-22. doi: 10.1111/chf.12037.

  PMID: 23910704 BACKGROUND

• Katta N, Balla S, Alpert MA. Does Long-Term Furosemide Therapy Cause Thiamine Deficiency in Patients with Heart Failure? A Focused Review. Am J Med. 2016 Jul;129(7):753.e7-753.e11. doi: 10.1016/j.amjmed.2016.01.037. Epub 2016 Feb 18.

  PMID: 26899752 BACKGROUND

• Suter PM, Vetter W. Diuretics and vitamin B1: are diuretics a risk factor for thiamin malnutrition? Nutr Rev. 2000 Oct;58(10):319-23. doi: 10.1111/j.1753-4887.2000.tb01827.x.

  PMID: 11127971 BACKGROUND

• Brady JA, Rock CL, Horneffer MR. Thiamin status, diuretic medications, and the management of congestive heart failure. J Am Diet Assoc. 1995 May;95(5):541-4. doi: 10.1016/S0002-8223(95)00148-4.

  PMID: 7722187 BACKGROUND

• Zenuk C, Healey J, Donnelly J, Vaillancourt R, Almalki Y, Smith S. Thiamine deficiency in congestive heart failure patients receiving long term furosemide therapy. Can J Clin Pharmacol. 2003 Winter;10(4):184-8.

  PMID: 14712323 BACKGROUND

• Shamir R, Dagan O, Abramovitch D, Abramovitch T, Vidne BA, Dinari G. Thiamine deficiency in children with congenital heart disease before and after corrective surgery. JPEN J Parenter Enteral Nutr. 2000 May-Jun;24(3):154-8. doi: 10.1177/0148607100024003154.

  PMID: 10850940 BACKGROUND

• Schoenenberger AW, Schoenenberger-Berzins R, der Maur CA, Suter PM, Vergopoulos A, Erne P. Thiamine supplementation in symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled, cross-over pilot study. Clin Res Cardiol. 2012 Mar;101(3):159-64. doi: 10.1007/s00392-011-0376-2. Epub 2011 Nov 5.

  PMID: 22057652 BACKGROUND

• Shimon I, Almog S, Vered Z, Seligmann H, Shefi M, Peleg E, Rosenthal T, Motro M, Halkin H, Ezra D. Improved left ventricular function after thiamine supplementation in patients with congestive heart failure receiving long-term furosemide therapy. Am J Med. 1995 May;98(5):485-90. doi: 10.1016/s0002-9343(99)80349-0.

  PMID: 7733128 BACKGROUND

• Yui Y, Itokawa Y, Kawai C. Furosemide-induced thiamine deficiency. Cardiovasc Res. 1980 Sep;14(9):537-40. doi: 10.1093/cvr/14.9.537.

  PMID: 7214397 BACKGROUND

• LeBlanc JG, Chain F, Martin R, Bermudez-Humaran LG, Courau S, Langella P. Beneficial effects on host energy metabolism of short-chain fatty acids and vitamins produced by commensal and probiotic bacteria. Microb Cell Fact. 2017 May 8;16(1):79. doi: 10.1186/s12934-017-0691-z.

  PMID: 28482838 BACKGROUND

• Rogovik AL, Vohra S, Goldman RD. Safety considerations and potential interactions of vitamins: should vitamins be considered drugs? Ann Pharmacother. 2010 Feb;44(2):311-24. doi: 10.1345/aph.1M238. Epub 2009 Dec 29.

  PMID: 20040703 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Beriberi

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Thiamine Deficiency; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Narumon Densupsoontorn, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Narumon Densupsoontorn, MD

CONTACT

662 4197000; narumon.den@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)