Restless Legs Syndrome And Blood Donation
Research type
Research Study
Full title
Study of the relationship between the severity of Restless Leg Syndrome (RLS) and periodic limb movements in sleep (PLMS) with low iron stores in blood donors
IRAS ID
260362
Contact name
David Roberts
Contact email
Sponsor organisation
NHS Blood and Transplant
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Restless legs syndrome (RLS) is a common but underdiagnosed syndrome. People with RLS complain of unpleasant symptoms such as tingling, burning and painful cramping sensations in the leg. These symptoms often occur when at rest and are worse in the afternoon or evening and relieved by movement. In 80% of cases, RLS is associated with difficulty getting to sleep and periodic limb movements (PLMs) of the foot and/or big toe. PLMs resemble jerky movements that can occur every 20-30 seconds on and off whilst awake or during sleep. The interruption of sleep results in daytime sleepiness, poor quality of life and worsened health conditions such as diabetes.
RLS can be diagnosed through use of the Cambridge-Hopkins questionnaire (CH-RLSq). The symptoms caused by RLS can also be measured objectively with actigraphy. Actigraphy resembles an activity tracker, such as a Fitbit device, and is strapped just below the toes of the foot to record PLMs.
There is evidence that diet influences the severity of RLS. Indeed RLS is likely to occur in individuals with low levels of iron. Iron is stored in the body as ferritin. The severity of RLS symptoms could therefore be reduced in some people with low ferritin through supplementation with iron. However, in some cases individuals with normal ferritin levels can still experience RLS. Since RLS can be inherited, it is also probable that responsiveness to treatment with iron is influenced by inherited genes. The combination in which these genes are inherited can be described by using genetic risk scores.
We hypothesise that the higher the risk score the greater is the likelihood of experiencing RLS when ferritin levels are normal. We would like to measure ferritin levels in blood donors and use actigraphy to determine how RLS changes with different genetic risk scores.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0317
Date of REC Opinion
26 Nov 2019
REC opinion
Further Information Favourable Opinion