Evaluation of PKU Sphere in Maternal PKU (Maternal PKU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04224142|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment|
|Maternal Phenylketonuria||Dietary Supplement: PKU sphere|
The aim of this study is to observe dietary management and metabolic control in women taking PKU sphere pre-conceptually and/or during pregnancy. To do this the following data points will be captured:
- Blood spot phenylalanine and tyrosine levels to measure metabolic control
- Changes to dietary management and any adaptations arising from incorporating PKU Sphere
- Compliance/adherence of patients to their recommended amount of protein substitute prescription.
- Tolerance of PKU sphere with respect to gastrointestinal (GI) symptoms and pregnancy associated nausea and vomiting.
- Acceptability of concurrent protein substitute(s) (if applicable).
- Nutritional status and weight management.
- Routine standard of care data on the final pregnancy outcome and postpartum.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||An Observational Study to Evaluate Metabolic Control and Dietary Management in Women With PKU Taking PKU Sphere During Pre-conception and/or Pregnancy|
|Actual Study Start Date :||July 29, 2019|
|Estimated Primary Completion Date :||July 29, 2021|
|Estimated Study Completion Date :||July 29, 2021|
PKU sphere (an FSMP) as per individual requirements determined by a dietitian.
Dietary Supplement: PKU sphere
PKU sphere is a Food for Special Medical Purposes (FSMP). This product is for use in the dietary management of phenylketonuria (PKU).
It is a powdered, low phenylalanine medical food containing a balanced mix of GMP, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and DHA.
It is available in 27g sachets providing 15g PE and contains 28mg Phe and 35g sachets providing 20g PE and contains 36mg Phe.
- Change in blood spot phenylalanine levels [ Time Frame: Baseline, 1-2 times weekly during preconception (max. 2 years), 2-3 times weekly during pregnancy, one month postpartum. ]Measurement of fasting phenylalanine concentrations completed once (1) to twice (2) weekly preconception (which may last for an indeterminate amount of time), twice (2) to three (3) times weekly during pregnancy and one month postpartum. Collected as dried bloodspots on Guthrie cards in the patient's own home and posted to the hospital laboratory for analysis.
- Change in blood spot tyrosine levels [ Time Frame: Baseline, 1-2 times weekly during preconception (max. 2 years), 2-3 times weekly during pregnancy, one month postpartum. ]Measurement of fasting tyrosine concentrations completed once (1) to twice (2) weekly preconception (which may last for an indeterminate amount of time), twice (2) to three (3) times weekly during pregnancy and one month postpartum. Collected as dried bloodspots on Guthrie cards in the patient's own home and posted to the hospital laboratory for analysis.
- Change in adherence to study product intake [ Time Frame: Every 12 weeks from baseline during preconception (max. 2 years) and pregnancy until the end of the pregnancy ]3-day diary recording compliance/adherence of patients to their prescribed amount of protein substitute.
- Participants' gastrointestinal adverse events [ Time Frame: Throughout the study until one month postpartum ]Participant to report any gastrointestinal (GI) symptoms and pregnancy-associated nausea and vomiting while consuming PKU Sphere.
- Change in weight [ Time Frame: Baseline, every 24 weeks during preconception (max. 2 years) and pregnancy, one month postpartum ]Weight (kg)
- Change in plasma amino acid profile [ Time Frame: Baseline, all routine results during preconception (max. 2 years) and pregnancy, one month postpartum ]Plasma amino acid profile
- Change in plasma micronutrient profile [ Time Frame: Baseline, all routine results during preconception (max. 2 years) and pregnancy, one month postpartum ]Plasma micronutrient profile
- Pregnancy outcome [ Time Frame: End of pregnancy ]Standard of care data on the outcome of the pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224142
|Contact: Karl Harvey||0151 709 9020 ext 300||Karl.Harvey@Vitaflo.co.uk|
|Contact: Clinical Trials||0151 709 9020||ClinicalTrialsTeam@Vitaflo.co.uk|
|NHS Greater Glasgow and Clyde||Recruiting|
|Glasgow, United Kingdom|
|Contact: Sarah Adam 0141 452 6451 Sarah.Adam@GGC.Scot.NHS.UK|
|University College London Hospitals NHS Foundation Trust||Recruiting|
|London, United Kingdom|
|Contact: Charlotte Ellerton 0203 448 4332 C.Ellerton@NHS.Net|
|Contact: Harriet Churchill 0203 448 3604 Harriet.Churchill@NHS.Net|
|Principal Investigator:||Charlotte Ellerton||University College London Hospitals|