Does the B-vitamin riboflavin lower blood pressure in individuals with high blood pressure who have a specific genetic make up?
| ISRCTN | ISRCTN23620802 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23620802 |
| Protocol serial number | N/A |
| Sponsor | University of Ulster (UK) |
| Funders | University of Ulster (UK), DSM Nutritional Products Ltd (UK) |
- Submission date
- 26/09/2011
- Registration date
- 02/02/2012
- Last edited
- 02/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
University of Ulster
Cromore Road
Coleraine, County Londonderry
BT52 1SA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled double-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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) |
| Study objectives | 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(s) | Office for Research Ethics Northern Ireland, 13/01/2010, ref: 09/NIR01/68 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Blood pressure |
| Key secondary outcome measure(s) |
Riboflavin status |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Individuals recruited previously who consented to being contacted regarding future studies 2. Individuals identified as having the TT genotype |
| Key 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 |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
BT52 1SA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
