| Methods |
Randomised controlled cross‐over trial. |
| Participants |
Number of participants: 25 enrolled, ages 2 to 10 years.
Inclusion criteria: well controlled plasma phenylalanine concentrations over the past 6 months; ages 2 to 10 years; parents able to collect blood specimens.
Exclusion criteria: none indicated. |
| Interventions |
Two doses of protein substitute for 14 days each with a 14‐day washout period.
1. 2 g/kg body weight/day
2. 1.2 g/kg body weight/day |
| Outcomes |
1. Plasma phenylalanine concentrations
2. Intakes of total protein, protein from protein substitute, protein from food, and phenylalanine exchanges
3. Intakes of total energy and energy from protein substitute |
| Notes |
Location: UK |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization process not described. |
| Allocation concealment (selection bias) |
Low risk |
Adequate. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not used. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Inclusion of all randomized participants in the final analysis. |
