No registrations found.
ID
Source
Brief title
Health condition
Healthy full-term infants
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight gain.
Secondary outcome
1. Recumbent length gain;
2. Increase in head circumference.
Background summary
This study aims to investigate the nutritional efficacy and suitability of two infant formulae with slightly modified composition in healthy full-term infants compared to a currently marketed infant formula primarily on weight gain in the first 16 weeks of life. A follow-up visit will take place at 52 weeks of life. During the intervention period parents will be asked to record gastrointestinal tolerance and formula intake. In a subgroup of infants (on a voluntary basis) a blood sample will be collected at the age of 16 weeks for nutritional status and safety.
Study objective
The investigational formulae are equivalent to the currently marketed control formula with regard to weight gain of healthy full-term infants during first 16 weeks of life.
Study design
Screening, baseline, visits on 4, 8, 12, 16, and 52 weeks.
Intervention
Duration of intervention: 14-16 weeks.
Intervention groups: Two investigational formulae with slightly modified composition.
Control group: the control formula is a currently marketed infant formula.
Lilian van Tuyl
Utrecht 3584 CT
The Netherlands
+31 (0)30 2095000
lilian.van-tuyl@nutricia.com
Lilian van Tuyl
Utrecht 3584 CT
The Netherlands
+31 (0)30 2095000
lilian.van-tuyl@nutricia.com
Inclusion criteria
1. Healthy full-term infants (gestational age > 37 and < 42 weeks, birth weight > 2.5 kg);
2. Infants with appropriate birth weight within normal range for gestational age and sex;
3. Infants aged <= 14 days at study entry;
4. Infants who are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ceased breastfeeding by time of inclusion);
5. Written informed consent from both parents.
Exclusion criteria
1. Infants with birth weight > 4.5 kg;
2. Infants diagnosed with a congenital illness or malformation that could affect normal growth;
3. Infants with significant pre- or postnatal disease;
4. Infants that are already participating in another clinical trial;
5. Infants with cows' milk allergy, soy allergy or lactose intolerance.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL2011 |
| NTR-old | NTR2128 |
| Other | Nutricia Research : All.3.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |