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Completed

NCT Number: NCT04278378

Blood Pressure Lowering Effect of B-vitamins in Adults With a Genetic Pre-disposition to Elevated Blood Pressure.

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MTHFR 677TT genotype, aged at least 18 years old

Exclusion criteria

  • Taking supplements containing B-vitamins
  • Pregnant or planning to conceive
  • Taking medications interfering with folate metabolism
  • Renal or gastrointestinal disease

Treatment and study plan

riboflavin

Dietary Supplement

1.6 mg riboflavin / day for 24 weeks

Folic Acid

Dietary Supplement

0.4 mg folic acid / day for 24 weeks

Placebo

Dietary Supplement

Primary outcomes

  1. Blood pressure

    Time frame: Change from baseline to 24 weeks

    Office blood pressure

Secondary outcomes

  1. Central blood pressure

    Time frame: Change from baseline to 24 weeks

    Measured using SphygmoCor device

  2. Pulse wave analysis

    Time frame: Change from baseline to 24 weeks

    Measured using SphygmoCor device

  3. Pulse wave velocity

    Time frame: Change from baseline to 24 weeks

    Measured using SphygmoCor device

  4. Red blood cell riboflavin

    Time frame: Change from baseline to 24 weeks

    Measured using erythrocyte glutathione reductase activity coefficient (EGRAC)

  5. Red blood cell folate

    Time frame: Change from baseline to 24 weeks

    Measured by microbiological assay

  6. Serum homocysteine

    Time frame: Change from baseline to 24 weeks

    Measured using an immunoassay

  7. Plasma vitamin B6

    Time frame: Change from baseline to 24 weeks

    Measured by High Performance Liquid Chromatography

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Registry information

Acronym: RAFA

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2020
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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