AzTrials
AzTrials

Heart DiseasesPhase 3NCT03989700

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

A Phase 3 study testing Thiamine Mononitrate in people with Heart Diseases, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 month to 15 years
Conditions the study is for
Heart Diseases
What is being tested?
Thiamine Mononitrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteThailand
Study dates
1 Jul 2019to 31 Jul 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Narumon Densupsoontorn, MD contact

662 4197000 ext. 5947

narumon.den@mahidol.ac.th

Thailand1 site

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs: Randomized Controlled Trial

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.

Read the 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.

Conditions
Heart Diseases
Being tested
Thiamine Mononitrate
Keywords
Diuretic drugs, Thiamin deficiency
Medical subject headings
Heart Diseases, Beriberi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thiamine MononitrateDrug

    Also called Vitamin B1

    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

Study groups in NCT03989700
Study groupRoleWhat they receive
Low doseExperimentalLow dose of thiamin supplementation
Receives: Drug: Thiamine Mononitrate
High doseExperimentalHigh dose of thiamin supplementation
Receives: Drug: Thiamine Mononitrate
PlaceboPlacebo comparatorplacebo supplementation
Receives: Drug: Thiamine Mononitrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in thiamin pyrophosphate effect

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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start1 Jul 2019 (estimated)
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989700
Sponsor's protocol ID
Si364/2019
Status last verified
Jun 2019
First submitted
14 Jun 2019
Last updated
20 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23910704

  • 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.

    PubMed 26899752

  • 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.

    PubMed 11127971

  • 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.

    PubMed 7722187

  • 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.

    PubMed 14712323

  • 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.

    PubMed 10850940

  • 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.

    PubMed 22057652

  • 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.

    PubMed 7733128

  • 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.

    PubMed 7214397

  • 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.

    PubMed 28482838

  • 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.

    PubMed 20040703

  • Sumboonnanonda R, Vijarnsorn C, Saengpanit P, Srisawat C, Chotipanang K, Junnu S, Kunnangja S, Rukprayoon H, Phuangphan P, Suiwongsa B, Liammongkolkul S, Laohathai P, Densupsoontorn N. Impact of thiamin supplementation on thiamin pyrophosphate effect and cardiac function in pediatric heart disease patients on diuretics: a randomized controlled trial. Sci Rep. 2026 Mar 23;16(1):14809. doi: 10.1038/s41598-026-45100-4.

    PubMed 41872295

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thiamine Mononitrate in people with Heart Diseases, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Narumon Densupsoontorn, MD (662 4197000 ext. 5947, narumon.den@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in thiamin pyrophosphate effect (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989700, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in