PKU sphere (an FSMP) as per individual requirements determined by a dietitian.

Maternal Phenylketonuria

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.

PKU sphere

NHS Greater Glasgow and Clyde

University College London Hospitals NHS Foundation Trust

Evaluation of PKU Sphere in Maternal PKU

An Observational Study to Evaluate Metabolic Control and Dietary Management in Women With PKU Taking PKU Sphere During Pre-conception and/or Pregnancy

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.

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.

3-day diary recording compliance/adherence of patients to their prescribed amount of protein substitute.

Participant to report any gastrointestinal (GI) symptoms and pregnancy-associated nausea and vomiting while consuming PKU Sphere.

Standard of care data on the outcome of the pregnancy

Vitaflo International, Ltd

University College London Hospitals

Daily feed, substituting the participant's normal phe-free protein substitute for PKU Explore.

Phenylketonuria

Inborn Errors of Metabolism

PKU Explore is an unflavoured, powdered, phenylalanine-free, protein substitute, containing essential and non-essential amino acids, carbohydrate, sugar, vitamins, minerals, trace elements and the long chain polyunsaturated fatty acids (LCPs); arachidonic acid (AA) and docosahexaenoic acid (DHA).

PKU Explore

Birmingham Women's and Children's NHS Foundation Trust

Bradford Teaching Hospitals NHS Foundation Trust

Evaluation of PKU Explore

A Study to Evaluate the Acceptability of PKU Explore, a Renovated Phenylalanine Free Second Stage Protein Substitute for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 5 Years of Age With Regard to Product Tolerance and Adherence.

Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.

Qualitative assessments from subject questionnaires that allow evaluation of any change in the gastro-intestinal tolerance of the study product.

Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.

Collection of quantitative data regarding phenylalanine control using routine biochemical testing

Daily feed, substituting the participant's normal phe-free formula for PKU Start.

PKU Start is a powdered, phenylalanine-free, infant formula, containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements and long chain polyunsaturated fatty acids (LCPs); Arachidonic acid (AA) and Docosahexaenoic acid (DHA). It is suitable for use from birth.
The recommended amount of the product for each participant will be determined and prescribed by a dietitian.

PKU Start

Birmingham Children's Hospital NHS Foundation Trust

Evaluation of PKU Start

A Study to Evaluate the Acceptability of a New Phenylalanine Free Infant Formula for Use in the Dietary Management of Phenylketonuria in Infants From Birth to 2 Year of Age With Regard to Product Tolerance and Adherence.

Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.

In this group, the patients received 100mg ferrous succinate and 200mg vitamin C three times per day for 3-4 months

In this group, the patients received 100mg ferrous succinate three times per day for 3-4 months

In this group, the patients received 200mg ferrous succinate three times per day for 3-4 months

Anemia, Iron-Deficiency

As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time

ferrous succinate and vitamin C

As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice

ferrous succinate

As another active comparator, patients take the tablets of ferrous succinate with double dosage

Hushan Hospital

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

The Efficacy and Safety of Vitamin C for Iron Supplementation Therapy in Adult Patients With Iron Deficiency Anemia(IDA)

The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the second week

The increased levels of reticulocyte after receiving three different treatment regimens are evaluated in the second week

The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the fourth week

The increased levels of ferritin after receiving three different treatment regimens are evaluated in the eighth week

The incidence of adverse events every two weeks are assessed, the adverse events include bellyache, diarrhea, constipation, vomiting, nausea.

phenylalanine/kutapika

Evaluation of PKU Sphere in Maternal PKU

Evaluation of PKU Explore

Evaluation of PKU Start

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

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