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

Overview

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

  • 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

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

  • 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

Primary 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

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 Eligibility: All

Minimum Age: 1 Month

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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, narumon.den@mahidol.ac.th

References

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. Review.

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. Review.

Suter PM, Vetter W. Diuretics and vitamin B1: are diuretics a risk factor for thiamin malnutrition? Nutr Rev. 2000 Oct;58(10):319-23. Review.

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.

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.

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.

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.

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.

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

LeBlanc JG, Chain F, Martín R, Bermúdez-Humarán 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. Review.

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. Review.

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