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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Hannah
Howlett
Hannah.Howlett@nca.nhs.uk
Miss
Marie
Meehan
marie.meehan@nca.nhs.uk
Helena
Tattersall
helena.tattersall@nca.nhs.uk
Fatma
Rumash
Fatma.Rumash@nca.nhs.uk
Karolina
Stepien
karolina.stepien@nca.nhs.uk
Mary
Gieschen-Krische
mary.gieschenkrische@nca.nhs.uk
Helen
Moffitt-Adams
helen.moffitt@nca.nhs.uk
Metabolic disorders
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Blood phenylalanine (Phe) levels are likely to change during the monthly period in women with PKU. We want to study this because some women report that when they started their period changes in Phe resulted in questions about adherence to the low protein diet. Women undergoing sapropterin testing have reported changes in Phe during their period which has complicated decisions around responsiveness.
We propose a feasibility pilot study recruiting 10 women aged under 40 years old from the metabolic unit at Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust. Women will be asked to complete a diary of their period for two months which will help decide the best days to plan tests for hormone and Phe levels. Hormone and Phe levels will be tested at specifically chosen time points during the different parts of the period (menstrual cycle), for 3 cycles to ensure we have representative results. Participants will be asked to complete a diary to check that any changes in Phe levels are not related to appetite or diet.
We will also complete a questionnaire study to find out whether and how periods have impacted on women’s experiences of having PKU.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Case-controlled study;
You can take part if:
You may not be able to take part if:
• Not on combined oral contraceptive pill, no coil fitted or on any other treatment which could affect female hormone levels e.g. anti-psychotic or anti-epileptic medication. • If just stopped oral contraceptive pill must have 2 natural cycles after stopping. • Has any condition such as polycystic ovary syndrome that could affect hormone levels. • Not on sapropterin to avoid the possibility of sapropterin induced variation within the sample. Women on sapropterin may have reduced variation of blood Phe levels. • Hyperphenylalaninaemia • Intensive physical activity (more than 30minutes daily in case of high intensity and 4 hours daily in case of low intensity activity) • Pregnancy, post menopause
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Hannah
Howlett
Hannah.Howlett@nca.nhs.uk
Mary
Gieschen-Krische
mary.gieschenkrische@nca.nhs.uk
Helen
Moffitt-Adams
helen.moffitt@nca.nhs.uk
Helena
Tattersall
helena.tattersall@nca.nhs.uk
Fatma
Rumash
Fatma.Rumash@nca.nhs.uk
Karolina
Stepien
karolina.stepien@nca.nhs.uk
Miss
Marie
Meehan
marie.meehan@nca.nhs.uk
The study is sponsored by NORTHERN CARE ALLIANCE NHS FOUNDATION TRUST and funded by THE NATIONAL SOCIETY FOR PHENYLKETONURIA (UNITED KINGDOM) LIMITED .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 70773
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
