RIBOGENE: Optimisation of Riboflavin Status in Hypertensive Adults With a Genetic Predisposition to Elevated Blood Pressure
RIBOGENE
1 other identifier
interventional
243
1 country
3
Brief Summary
Approximately 10% of the world's population have a particular genetic makeup (known as the TT genotype) that may increase their risk of having higher blood pressure. Previous work conducted by the investigators research group at the University of Ulster, in collaboration with clinical colleagues from across Northern Ireland, in premature CVD patients and hypertensive adults generally has demonstrated that a dietary level of riboflavin (1.6mg/d) decreases blood pressure, specifically in those with the TT genotype. To date, the blood pressure lowering effects of higher doses of riboflavin in individuals with the TT genotype is not known. The aim of this study is to investigate whether supplementation with riboflavin at a low dose supplemental level (10mg/d) can decrease blood pressure more effectively than the dietary level (1.6mg/d) by optimising riboflavin status and normalising MTHFR activity. This aim will be achieved by conducting a double-blind placebo-controlled intervention study over a 16 week period. Participants will be recruited from cohorts screened for the methylenetetrahydrofolate reductase (MTHFR) C677T polymorphism. Those identified with the TT genotype (homozygous for the polymorphism) that wish to participate in this research will be asked to attend a baseline and week-16 appointment and will be asked to take a daily riboflavin (1.6 or 10mg/d) or placebo capsule for the duration of the study. At each appointment a blood sample will be taken and blood pressure, height, weight and waist circumference will be measured. If the results of this study show that intervention with a higher dose of riboflavin can lower blood pressure more effectively in individuals with the TT genotype this will have important implications for those responsible for the management of blood pressure. The findings will be of particular relevance in populations with a higher prevalence of the polymorphism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 13, 2016
May 1, 2016
4.8 years
June 2, 2015
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Pressure
The aim of this study is to investigate whether a low dose supplemental level (10mg/d) of riboflavin can decrease blood pressure more effectively than the dietary level (1.6mg/d) by optimising riboflavin status and normalising MTHFR activity.
16 weeks
Secondary Outcomes (5)
Erythrocyte Glutathione Reductase Activation Coefficient (EGRAC)
16 weeks
Plasma Homocysteine
16 weeks
Red cell folate
16 weeks
Vitamin B12
16 weeks
Vitamin B6
16 weeks
Study Arms (3)
Treatment 1
PLACEBO COMPARATORTreatment 2
ACTIVE COMPARATORTreatment 3
ACTIVE COMPARATORInterventions
2 week placebo washout + 16 weeks intervention (placebo)
2 week placebo washout + 16 weeks intervention (1.6mg riboflavin per day)
2 week placebo washout + 16 weeks intervention (10mg riboflavin per day)
Eligibility Criteria
You may qualify if:
- Over 18 years old
You may not qualify if:
- History of gastrointestinal; Hepatic; Renal or haematological disorders
- Taking B-vitamin supplements (including multi-vitamins containing B-vitamins), anticonvulsant therapy or any other drugs known to interfere with folate/B-vitamin metabolism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ulsterlead
- DSM Nutritional Products, Inc.collaborator
Study Sites (3)
Northern Ireland Clinical Research Facility (NICRF)
Belfast, N.Ireland, BT9 7AB, United Kingdom
Human Intervention Studies Unit, University of Ulster
Coleraine, N.Ireland, BT52 1SA, United Kingdom
Clinical Translational Research and Innovation Centre (C-TRIC)
Londonderry, N.Ireland, BT47 6SB, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 4, 2015
Study Start
February 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 13, 2016
Record last verified: 2016-05