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van CCT (UK)

Effects of a nutrient dense infant formula on the growth and tolerance of infants compared to current practice in Spain.

- candidate number3040
- NTR NumberNTR1199
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jan-2008
- Secondary IDs100.153 Numico Research B.V.
- Public TitleEffects of a nutrient dense infant formula on the growth and tolerance of infants compared to current practice in Spain.
- Scientific TitleA randomized, controlled, open-label, parallel-arm, multi-centre intervention trial on the effect of a nutrient dense infant formula compared to current practice, on the growth and tolerance of infants in Spain.
- hypothesisA nutrient dense infant formula promotes growth more effectively than current practice.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. Infants aged 0 to 9 months;
2. Infants with increased energy requirements and/or fluid restrictions and/or with indication for using high-energy feeds;
3. The infants must be new consumers of oral high-energy feeds;
4. Infants must have an expected requirement for the study product for at least 6 weeks, with an expected study product intake of, on average, at least 50% of their energy intake;
5. Written parental informed consent must be available.
- Exclusion criteria1. Infants with cow's milk intolerance, major gastrointestinal hepatic or renal dysfunction, or inherited metabolic disorders including galactosaemia are excluded for this study;
2. Investigator's uncertainty about the willingness or ability of the caretaker to comply with the protocol requirements;
3. Participation in any other studies with investigational or marketed products concomitantly or within two weeks prior to entry into this study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate1-sep-2009
- Target number of participants80
- InterventionsDuration intervention: 6-12 weeks. Intervention group: a high energy, high protein and nutrient dense, nutritionally complete, ready-to-use feed for infants 0-12 months. Control group: constitutes all infant formulas used as part of "current practice" in Spain for infants with increased energy requirements and/or fluid restrictions.
- Primary outcomeIncrease in Z-score for length at 6 weeks relative to baseline.
- Secondary outcomeAnthropometrics, gastrointestinal tolerance, fecal microbiology and dietary intake.
- TimepointsBaseline, and follow up measurements at 3 weeks, 6 weeks (and 9 weeks and 12 weeks, in case of optional extension period) after baseline.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryThe aim of this study is to compare the effects, with regard to growth, of a nutrient dense infant formula to the effect of current practice in Spain in infants requiring a high-energy feed. Therefore, subjects will receive either a nutrient dense infant formula or current practice for a period of 6 weeks. An optional 6-week extension period is offered to all subjects completing the initial 6-week study period. Baseline anthropometrics measurements will be collected and repeated outcomes will be measured during hospital visits at week 3, 6, 9, and 12. Tolerance to the feed will be recorded weekly and a 3-day food diary will be completed to evaluate the intake of other foods/drinks. Subject's blood and stool samples will be collected at baseline, 6 weeks, and 12 weeks for the analysis of safety parameters and fecal microbiota respectively.
- Main changes (audit trail)
- RECORD30-jan-2008 - 2-mrt-2013

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