Blood PressureRAFANCT04278378
Blood Pressure Lowering Effect of B-vitamins in Adults With a Genetic Pre-disposition to Elevated Blood Pressure.
A study testing Riboflavin and Folic acid in people with Blood Pressure, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Approximately 12% of the world's population have a have a common C677T polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (MTHFR). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Riboflavin and Folic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,564 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2011to 15 Aug 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MTHFR 677TT genotype, aged at least 18 years old
Who cannot join
- Taking supplements containing B-vitamins
- Pregnant or planning to conceive
- Taking medications interfering with folate metabolism
- Renal or gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
Approximately 12% of the world's population have a have a common C677T polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (MTHFR). Homozygosity for the polymorphism (TT genotype) causes an increased requirement for the B-vitamins folic acid and riboflavin and more importantly results in an increased risk of developing high blood pressure (BP). Previous work from our Centre has demonstrated significantly higher BP in those with the TT genotype. This work has been conducted in cohorts with premature cardiovascular disease (CVD) and hypertension without overt CVD, but the effect in younger, healthier individuals is unexplored. To date our studies have also focused on BP as the primary outcome, but newer markers of vascular health including central pressure and hemodynamics have emerged as superior prognostic indicators of CVD. The effect of the TT genotype on these measures is an area for investigation and may help us understand the mechanism linking the genotype with BP, which is currently unknown. As adults with the TT genotype have increased requirements for riboflavin and folic acid, and BP in TT adults appears to be riboflavin dependent, the influence of these vitamins on central measures is an area for consideration. Study Design This is an observational study investigating the blood pressure profiles of healthy adults aged 18-65 years, stratified by MTHFR genotype. Apparently healthy adults will be recruited from workplaces and the general community across Northern Ireland and screened for the polymorphism via buccal swab. Those with the TT genotype and a similar number of non-TT (i.e. CC/CT) genotype individuals will be contacted and asked to come to a one-off appointment. Brachial BP will be assessed by an electronic BP monitor, central BP and central haemodynamics (augmentation index, augmentation pressure and pulse wave velocity) will be assessed by SphygmoCor XCEL. In addition, anthropometric measurements, health and lifestyle infromation and a blood sample will be obtained. Data will be statistically analysed using SPSS software to if determine differences between gentoype groups exist.
- Conditions
- Blood Pressure
- Being tested
- Riboflavin, Folic acid, Placebo
- Keywords
- Blood pressure, Central hemodynamics, Methylenetetrahydrofolate reductase (MTHFR), Folate polymorphism, Riboflavin, Folic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDietary supplement
1.6 mg riboflavin / day for 24 weeks
Folic acidDietary supplement
0.4 mg folic acid / day for 24 weeks
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Riboflavin | Active comparator | 1.6 mg riboflavin / day for 24 weeks Receives: Dietary Supplement: Riboflavin |
| Folic Acid | Experimental | 0.4 mg folic acid/ day for 24 weeks Receives: Dietary Supplement: Folic acid |
| Riboflavin + Folic Acid | Experimental | 1.6mg Riboflavin + 0.4 mg Folic Acid / day for 24 weeks Receives: Dietary Supplement: Riboflavin; Dietary Supplement: Folic acid |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Office blood pressure
Measured: Change from baseline to 24 weeks
Secondary outcomes (7)
Central blood pressure
Measured using SphygmoCor device
Measured: Change from baseline to 24 weeks
Pulse wave analysis
Measured using SphygmoCor device
Measured: Change from baseline to 24 weeks
Pulse wave velocity
Measured using SphygmoCor device
Measured: Change from baseline to 24 weeks
Red blood cell riboflavin
Measured using erythrocyte glutathione reductase activity coefficient (EGRAC)
Measured: Change from baseline to 24 weeks
Red blood cell folate
Measured by microbiological assay
Measured: Change from baseline to 24 weeks
Serum homocysteine
Measured using an immunoassay
Measured: Change from baseline to 24 weeks
Plasma vitamin B6
Measured by High Performance Liquid Chromatography
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start28 Jun 2011
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278378
- Sponsor's protocol ID
- REC/11/0081
- Acronym
- RAFA
- Status last verified
- Jun 2021
- First submitted
- 17 Feb 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Lowering Effect of B-vitamins in Adults With a Genetic Pre-disposition to Elevated Blood Pressure.
- ClinicalTrials.gov ID
- NCT04278378
- Acronym / sponsor ID
- RAFA / REC/11/0081
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Central hemodynamics, Methylenetetrahydrofolate reductase (MTHFR), Folate polymorphism, Riboflavin, Folic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,564 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- 28 Jun 2011 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 12% of the world's population have a have a common C677T polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (MTHFR). Homozygosity for the polymorphism (TT genotype) causes an increased requirement for the B-vitamins folic acid and riboflavin and more importantly results in an increased risk of developing high blood pressure (BP). Previous work from our Centre has demonstrated significantly higher BP in those with the TT genotype. This work has been conducted in cohorts with premature cardiovascular disease (CVD) and hypertension without overt CVD, but the effect in younger, healthier individuals is unexplored. To date our studies have also focused on BP as the primary outcome, but newer markers of vascular health including central pressure and hemodynamics have emerged as superior prognostic indicators of CVD. The effect of the TT genotype on these measures is an area for investigation and may help us understand the mechanism linking the genotype with BP, which is currently unknown. As adults with the TT genotype have increased requirements for riboflavin and folic acid, and BP in TT adults appears to be riboflavin dependent, the influence of these vitamins on central measures is an area for consideration. Study Design This is an observational study investigating the blood pressure profiles of healthy adults aged 18-65 years, stratified by MTHFR genotype. Apparently healthy adults will be recruited from workplaces and the general community across Northern Ireland and screened for the polymorphism via buccal swab. Those with the TT genotype and a similar number of non-TT (i.e. CC/CT) genotype individuals will be contacted and asked to come to a one-off appointment. Brachial BP will be assessed by an electronic BP monitor, central BP and central haemodynamics (augmentation index, augmentation pressure and pulse wave velocity) will be assessed by SphygmoCor XCEL. In addition, anthropometric measurements, health and lifestyle infromation and a blood sample will be obtained. Data will be statistically analysed using SPSS software to if determine differences between gentoype groups exist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Riboflavin | Active comparator | Dietary Supplement: Riboflavin1.6 mg riboflavin / day for 24 weeks |
| Folic Acid | Experimental | Dietary Supplement: Folic acid0.4 mg folic acid/ day for 24 weeks |
| Riboflavin + Folic Acid | Experimental | Dietary Supplement: Riboflavin, Dietary Supplement: Folic acid1.6mg Riboflavin + 0.4 mg Folic Acid / day for 24 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MTHFR 677TT genotype, aged at least 18 years old
Key exclusion criteria (4 listed)
- Taking supplements containing B-vitamins
- Pregnant or planning to conceive
- Taking medications interfering with folate metabolism
- Renal or gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riboflavin1.6 mg riboflavin / day for 24 weeks | Dietary supplement | Riboflavin, Riboflavin + Folic Acid |
| Folic acid0.4 mg folic acid / day for 24 weeks | Dietary supplement | Folic Acid, Riboflavin + Folic Acid |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Blood pressure
Time frame: Change from baseline to 24 weeks
Office blood pressure
7 secondary outcomes
Central blood pressure
Time frame: Change from baseline to 24 weeks
Pulse wave analysis
Time frame: Change from baseline to 24 weeks
Pulse wave velocity
Time frame: Change from baseline to 24 weeks
Red blood cell riboflavin
Time frame: Change from baseline to 24 weeks
Red blood cell folate
Time frame: Change from baseline to 24 weeks
Serum homocysteine
Time frame: Change from baseline to 24 weeks
Plasma vitamin B6
Time frame: Change from baseline to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riboflavin and Folic acid in people with Blood Pressure, run by University of Ulster at 1 site in United Kingdom.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jun 2021. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Change from baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2021.