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Does the B-vitamin riboflavin lower blood pressure in individuals with high blood pressure who have a specific genetic make up?
ISRCTN ISRCTN23620802
DOI 10.1186/ISRCTN23620802
ClinicalTrials.gov identifier
EudraCT number
Public title Does the B-vitamin riboflavin lower blood pressure in individuals with high blood pressure who have a specific genetic make up?
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 N/A
Serial number at source N/A
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).
Lay summary Lay summary under review 3
Ethics approval Office for Research Ethics Northern Ireland, 13 January 2010 ref: 09/NIR01/68
Study design Randomised placebo-controlled double-blind trial
Countries of recruitment United Kingdom
Disease/condition/study domain Hypertension
Participants - inclusion criteria 1. Individuals recruited previously who consented to being contacted regarding future studies
2. Individuals identified as having the TT genotype
Participants - 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
Anticipated start date 01/05/2010
Anticipated end date 01/01/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Total recruitment target n=80
Interventions Double-blind randomised controlled riboflavin (1.6mg/d/16weeks) placebo controlled trial in hypertensive individuals with the TT genotype
Primary outcome measure(s) Blood pressure
Secondary outcome measure(s) Riboflavin status
Sources of funding 1. University of Ulster (UK)
2. DSM Nutritional Products Ltd (UK)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23608654
Contact name Dr  Mary  Ward
  Address University of Ulster
Cromore Road
  City/town Coleraine, County Londonderry
  Zip/Postcode BT52 1SA
  Country United Kingdom
Sponsor University of Ulster (UK)
  Address c/o Mr Nick Curry
Shore Road
  City/town Newtonabbey, County Antrim
  Zip/Postcode BT37 OQB
  Country United Kingdom
  Sponsor website: http://www.ulster.ac.uk/
Date applied 26/09/2011
Last edited 10/07/2013
Date ISRCTN assigned 02/02/2012
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