Raynaud Phenomenon Clinical Trial
Official title:
Beet the Cold: The Effect of Inorganic Nitrate Supplementation on Peripheral Blood Flow and Pain in Individuals With Raynaud's Phenomenon. A Pilot, Double-blind, Placebo Controlled, Randomised Crossover Trial
NCT number | NCT03129178 |
Other study ID # | 001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | October 1, 2018 |
Verified date | September 2019 |
Source | University of Portsmouth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Individuals with Raynaud's phenomenon often experience episodes of reduced blood flow to
their fingers and toes during times of stress or cold exposure, causing significant
discomfort and pain. Typically, treatment for these individuals involves using drugs like
Glyceryl Trinitrate (GTN), which increases blood flow to the fingers and toes by increasing a
substance called nitric oxide in the blood. Unfortunately, repeated use of these drugs
increases tolerance to them, meaning higher doses are required to produce the same effect.
However, increasing the dose can cause more side effects like headaches, and is therefore not
considered an ideal long-term therapy.
Leafy green vegetables, especially beetroot, contain high amounts of nitrate and are
beneficial to blood vessel health, since nitrate from the diet can also be turned into the
important blood vessel relaxer, nitric oxide. Unlike GTN, people don't appear to develop a
tolerance to dietary nitrate or experience negative side effects.
Therefore, this study aims to see if short and longer term beetroot juice supplementation can
improve blood flow to the hands and feet in individuals with Raynaud's phenomenon, as well as
reduce their pain. This study will tell us how many people are needed for a definitive trial
investigating whether beetroot juice can help treat Raynaud's phenomenon.
Raynaud's phenomenon can cause significant discomfort and pain to individuals. Dietary
nitrate appears to offer a simple, low cost means of improving blood flow to the hands and
feet which should reduce both the discomfort and pain experienced characterising this
condition. This study will advance our understanding of the causes of Raynaud's phenomenon,
specifically the role that the nitrate-nitrite-nitric oxide pathway might play in changing
Raynaud's phenomenon symptoms and identifying targets for intervention.
Status | Completed |
Enrollment | 27 |
Est. completion date | October 1, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or Female, aged 18 years or above. - Diagnosed with Raynaud's Phenomenon. - Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: The participant may not enter the study if ANY of the following apply: - Patients with significant renal impairment (eGFR<30) - Uncontrolled hypertension, - Taking regular organic nitrates, nicorandil, or thiazolidinidiones, - or any medication which may interfere with data interpretation or safety, - who have had a myocardial infarction or cerebro-vascular event, - who smoke, - or any other serious medical condition which would interfere with data interpretation or safety will be excluded from participation. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Sport and Exercise Science | Portsmouth | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Portsmouth | Loughborough University, University of Exeter |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peripheral Blood Flow | Peripheral blood flow (CVC = skin flux/MAP; flux.mmHg-1). | Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36). | |
Primary | Skin Temperature. | Skin temperature (via thermal imaging). | Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36). | |
Secondary | Perceived Discomfort | Perceived discomfort. Thermal discomfort were measured using a 20 cm scale (0 = very cold/uncomfortable; 10 = neutral; 20 = very hot/comfortable; modified from Zhang et al. (2004)) and recorded prior to immersion, during immersion and every 2 minutes of the rewarming period. |
Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36). | |
Secondary | Acceptability to Participants | Interview. Specifically, semi-structured interviews explored participants' experiences of the study procedures and consumption of beetroot juice. Interviews were conducted by a researcher with experience in qualitative research methods. Interviews were recorded, transcribed verbatim, and analysed through thematic analysis as outlined by Braun and Clarke (2006). Participants were asked about the testing procedures and their thoughts on the juice. | During qualitative interviews after the intervention has ended (post day 36). | |
Secondary | Overall Number of Participants Recruited | Number of participants who remained in the study | From start of study recruitment until the last participant is randomised. Estimated assesment period 6 - 52 weeks | |
Secondary | Perceived Pain | Perceived pain. Pain sensation was assessed using a numerical rating scale for pain (0 no pain, 10 unimaginable, unspeakable pain; (Ferreira-Valente et al., 2011)) at the same time points. |
Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36). | |
Secondary | Feasible to Participants | Feasible to participants via interview. Specifically, semi-structured interviews explored participants' experiences of the study procedures and consumption of beetroot juice. Interviews were conducted by a researcher with experience in qualitative research methods. Interviews were recorded, transcribed verbatim, and analysed through thematic analysis as outlined by Braun and Clarke (2006). | During qualitative interviews after the intervention has ended (post day 36). | |
Secondary | Establish Retention Rates | Establish retention rates (Descriptive statistics) | From date of randomization until the end of the last study visit. Estimated assesment period 6 - 52 weeks |
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