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Table 2 Demographic informations and clinical characteristics of subjects

From: Phenylalanine free infant formula in the dietary management of phenylketonuria

Subject number

Sex

Age at baseline  (weeks)

Ethnicity

PKU classification a

% (Number) of days completed in Part I

% (Number) of months completed in Part II

Protein substitute profile at pre-baseline

Source of natural protein

Commencement of solid intake

Number of different protein substitutes/day

Type of protein substitutes

Number of doses/day

Total protein equivalent from all protein substitutes (g/day)

Protein equivalent  from Phe-free infant formula b g/day (%)

1

M

32

Caucasian

Mild

50% (14)

Withdrawn

2

Infant powder and weaning semi-solid

3

20

5 (25%)

Standard infant formula / solid food

26 weeks

2

M

36

Caucasian

Classical

100% (28)

100% (12)

2

Infant powder and weaning semi-solid

3

29

10 (35%)

Solid food

16 weeks

3

M

8

Caucasian

Classical

100% (28)

Withdrawn

1

Infant powder

6

5

5 (100%)

Breast milk

Not applicable

4

F

6

Caucasian

Classical

100% (28)

100% (12)

1

Infant powder

5

6

6 (100%)

Standard infant formula

Not applicable

5

M

10

Pakistani Asian

Mild

100% (28)

100% (12)

1

Infant powder

7

8

8 (100%)

Standard infant formula

Not applicable

6

F

32

Caucasian

Classical

100% (28)

Withdrawn

2

Infant powder and weaning semi-solid

3

20

10 (50%)

Standard infant formula / solid food

17 weeks

7

M

18

Caucasian

Classical

100% (28)

100% (12)

1

Infant powder

6

14

14 (100%)

Standard infant formula

Not applicable

8

M

17

Caucasian

Classical

100% (28)

100% (12)

1

Infant powder

4

10

10 (100%)

Standard infant formula

Not applicable

9

M

4

Caucasian

Classical

100% (28)

100% (12)

1

Infant powder

5

9

9 (100%)

Standard infant formula

Not applicable

10

M

6

Caucasian

Classical

100% (28)

83% (10)

1

Infant powder

6

14

14 (100%)

Standard infant formula

Not applicable

  1. Part I: short-term evaluation over 28 days. Part II: extended follow-up for 12 months
  2. PKU, phenylketonuria; M, male; F, female
  3. aMild PKU with pre-treatment phenylalanine levels of 360–600 μmol/L, and classical PKU with pre-treatment phenylalanine > 1200 μmol/L
  4. bProtein equivalent intake (g/day) from the pre-baseline phenylalanine-free infant formula (PKU Anamix infant, Nutricia)