Last reviewed · How we verify
NCT05488106: InteRVENE
Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults
NA trial testing Placebo in Blood Pressure in 120 participants. Status unknown.
30 June 2023
Quick facts
| Lead sponsor | University of Ulster |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 September 2022 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Placebo
- Riboflavin 1.6mg/d
- Riboflavin 5mg/d
- Riboflavin 20mg/d
Conditions studied
- Blood Pressure — all drugs for Blood Pressure →
- Hypertension — all drugs for Hypertension →
Sponsor
University of Ulster
Who can join
Adults 18 to 60, male only, with Blood Pressure or Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
High blood pressure is the leading risk factor for heart disease and stroke. Approximately 12% of the population have a particular genetic factor (known as the TT genotype) which increases the risk of high blood pressure. Previous studies conducted at this centre have shown that taking the B-vitamin riboflavin, for up to 3 months, decreases blood pressure in adults with the TT genotype. It is currently not known how riboflavin lowers blood pressure in those with the TT genotype but it could be as a result of altering blood levels of nitric oxide. Nitric oxide causes blood vessels to expand, leading to improved blood vessel function, an important predictor of cardiovascular health. However, the effect of riboflavin supplementation on nitric oxide and blood vessel function has not been previously studied. Furthermore, it is unclear whether taking riboflavin over a shorter period of time or at doses higher than 1.6 mg/d can also lower blood pressure and improve blood vessel function in this at risk group. Therefore, the aim of this study is to assess the effects of riboflavin supplementation on blood pressure, biomarkers of nitric oxide bioavailability and blood vessel function. It is hypothesised that riboflavin supplementation will increase nitric oxide bioavailability, leading to reduced blood pressure and improved blood vessel function and, and that a higher riboflavin dose will lead to greater reductions in blood pressure.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Riboflavin supplements for blood pressure lowering in adults.
Bradbury KE, Coffey S, Earle N, Ni Mhurchu C, et al · · 2025 · PMID 41123035 · DOI 10.1002/14651858.cd015464.pub2
Verify or expand the search:
- PubMed search for NCT05488106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Blood Pressure
Currently open trials in the same condition.
- NCT07070583 — Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure · NA · recruiting
- NCT07396636 — Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment · recruiting
- NCT06719518 — Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device · recruiting
- NCT07319117 — Evaluation of the Impact of a Nutritional Formulation on Cognitive Performance Following Stress Exposure. · NA · recruiting
- NCT06837181 — Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM) · recruiting
Other University of Ulster trials
Trials by the same sponsor.
- NCT07253155 — Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity. · NA · enrolling by invitation
- NCT06667505 — To Test an e-Health Educational Intervention Patients With an ICD · NA · recruiting
- NCT06945003 — Study of Exercise Capacity and Physical Activity in Children With Congenital Heart Disease · NA · not yet recruiting
- NCT06914804 — Stomasense: A New Route to the Proactive Detection and Management of Leaks Within Ostomy Pouches · NA · enrolling by invitation
- NCT06921811 — Bioavailability From Chickpea Meals in Ileostomists? · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05488106 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Ulster
- Last refreshed: 9 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05488106.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing