Condition category
Circulatory System
Date applied
26/09/2011
Date assigned
02/02/2012
Last edited
02/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Around 10% of the population have a particular genetic make-up (known as the TT genotype) which may increase their risk of having high blood pressure (hypertension). Studies have shown that taking riboflavin (vitamin B2) supplements can decrease blood pressure specifically in premature heart disease patients with the TT genotype. The aim of this current study is to examine whether riboflavin can decrease blood pressure in patients with high blood pressure and the TT genotype generally.

Who can participate?
Patients who previously took part in two ongoing studies at our centre and identified as having both high blood pressure and the TT genotype.

What does the study involve?
Participants will be randomly allocated to take either riboflavin or placebo (dummy) tablets for 16 weeks.

What are the possible benefits and risks of participating?
If the results of this study show that riboflavin can lower blood pressure in people with the TT genotype then this could have important implications for the management and treatment of high blood pressure in this specific group.

Where is the study run from?
University of Ulster (UK).

When is the study starting and how long is it expected to run for?
May 2010 to January 2013.

Who is funding the study?
1. University of Ulster (UK)
2. DSM Nutritional Products Ltd (UK)

Who is the main contact?
Dr Mary Ward

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mary Ward

ORCID ID

Contact details

University of Ulster
Cromore Road
Coleraine
County Londonderry
BT52 1SA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An interventional study to investigate the effect of riboflavin supplementation (1.6mg/d/16weeks) on blood pressure in hypertensive individuals who are homozygous for the 677Câ T polymorphism (TT genotype) in the gene encoding the enzyme methylenetetrahydrofolate reductase (MTHFR)

Acronym

Study hypothesis

Riboflavin supplementation will result in a significant decrease in blood pressure in a specific group of hypertensive patients.

The aim of this study is to determine if riboflavin can lower blood pressure in hypertensive patients with the TT genotype. This will be achieved by conducting a double-blind placebo-controlled intervention study (1.6mg/day riboflavin or placebo for 16 weeks).

Ethics approval

Office for Research Ethics Northern Ireland, 13/01/2010, ref: 09/NIR01/68

Study design

Randomised placebo-controlled double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension

Intervention

Double-blind randomised controlled riboflavin (1.6mg/d/16 weeks) placebo-controlled trial in hypertensive individuals with the TT genotype

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Blood pressure

Secondary outcome measures

Riboflavin status

Overall trial start date

01/05/2010

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals recruited previously who consented to being contacted regarding future studies
2. Individuals identified as having the TT genotype

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Total recruitment target n=80

Participant exclusion criteria

1. A history of gastrointestinal, hepatic, renal or haematological disorders
2. Are taking B vitamin supplements, anticonvulsant therapy or any other drugs known to interfere with folate / B vitamin metabolism

Recruitment start date

01/05/2010

Recruitment end date

01/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Ulster
Coleraine, County Londonderry
BT52 1SA
United Kingdom

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

c/o Mr Nick Curry
Shore Road
Newtonabbey
County Antrim
BT37 OQB
United Kingdom

Sponsor type

University/education

Website

http://www.ulster.ac.uk/

Funders

Funder type

University/education

Funder name

University of Ulster (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Ireland

Funder name

DSM Nutritional Products Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23608654

Publication citations

  1. Results

    Wilson CP, McNulty H, Ward M, Strain JJ, Trouton TG, Hoeft BA, Weber P, Roos FF, Horigan G, McAnena L, Scott JM, Blood pressure in treated hypertensive individuals with the MTHFR 677TT genotype is responsive to intervention with riboflavin: findings of a targeted randomized trial., Hypertension, 2013, 61, 6, 1302-1308, doi: 10.1161/HYPERTENSIONAHA.111.01047.

Additional files

Editorial Notes