The primary objective of this study is to establish the clinically relevance of extra protein supplementation on the height growth at children with Cystic Fibrosis. The secondary objectives of this study are to measure the effects of protein…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the differences in heigth and lean body mass.
Based on these parameters, the growth will be determined. The side effect
parameters are the differences in weight and urea.
Secondary outcome
The side effect parameters are the differences in weight and urea.
Background summary
Children with cystic fibrosis (CF) have less net protein anabolism than
children without CF, and the result is retarded growth in the CF patients.
Numerous factors are likely to contribute to growth impairment and delayed
puberty in children with CF. The major factors that adversely affect growth are
malnutrition (from malabsorption, inadequate intake and increased
requirements), chronic inflammation, diabetes mellitus, liver disease, lung
disease and corticosteroid treatment. The protein intake above that recommended
by the CF Foundation would further stimulate whole-body protein synthesis.
Study objective
The primary objective of this study is to establish the clinically relevance of
extra protein supplementation on the height growth at children with Cystic
Fibrosis. The secondary objectives of this study are to measure the effects of
protein supplementation on the lean body mass by CF children with a retarded
growth.
Study design
The study is a cross-over randomized controlled trial, which each patient
served as his or her own control subject for protein supplementation.
Intervention
Each patient will receive in random order above the normal recommended feeding
intake 2 g protein extra * kg*1 * d*1 in the form of protein powder. The
energy, fat and carbohydrate intakes stay the same. Each patient crossing over
in effect serves as their own control. The data are analyzed according to the
original intention to treat.
Study burden and risks
Subjects are expected for 3 Ă 4 months for a control, additional to this
control for this study the body composition will be measured with the BIA and
the growth will be determined with different parameters. Before this control is
kept up a 3dd food record. (Appendix I)
The protein supplement is a commercially available safe protein powder. No
risks are involved.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Boys and girls with the age 4*12 y
* Prepubertal status
* Mild lung disease (FEV1 >75%)
* Informed consent signed by parents
Exclusion criteria
* Possible use of Corticosteroid
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28495.018.09 |