|- candidate number||13503|
|- NTR Number||NTR3683|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2012|
|- Secondary IDs||EPI.1.C/A Danone Research|
|- Public Title||A safety and growth study with a new fat blend.|
|- Scientific Title||A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.|
|- hypothesis||Based on the human milk composition, Nutricia Research has developed a new infant formula with a new fat blend, more similar to that of human milk. This new formula is currently being studied for safety and its effects on growth.|
The comparator used in the study is a standard infant formula containing the standard fat blend.
|- Healt Condition(s) or Problem(s) studied||Healthy children, Early feeding |
|- Inclusion criteria||1. Healthy term (gestational age >= 37 1/7 and <= 42 6/7 weeks);|
2. Age <= 35 days (preferably as soon as possible after birth);
3. Birth weight within normal range (10th to 90th percentile);
4. Exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ended breastfeeding by time of inclusion);
Exclusively breastfed (mothers willing to exclusively breastfeed at least till 13 weeks of age (and preferably till 17 weeks of age);
5. Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.
|- Exclusion criteria||1. Known current or previous illnesses/conditions or intervention which could interfere with the study or its outcome parameters;|
2. Mother known to suffer from hepatitis B or human immunodeficiency virus (HIV);
3. Need to be fed with a special diet other than standard (non hydrolysed) cowˇ®s milk-based infant formula;
4. Currently participating or have participated in any other study involving investigational or marketed products;
5. Incapability of the parent(s) to comply with study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-sep-2012|
|- planned closingdate||31-dec-2014|
|- Target number of participants||313|
|- Interventions||Duration of intervention: 13-17 weeks.|
Intervention group: Standard infant formula containing the new fat blend.
Control group: Standard infant formula containing the standard fat blend.
Reference group (no intervention): Human milk.
|- Primary outcome||To investigate equivalence of weight gain from randomisation until the age of 17 weeks.|
|- Secondary outcome||1. To investigate equivalence of other growth parameters;|
2. To assess gastrointestinal tolerance and safety.
|- Timepoints||1. V2 (Week 4);|
2. V3 (Week 8);
3. V4 (week 13);
4. V5 (Week 17).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. S. Schoen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D. Acton|
|- Sponsor/Initiator ||Nutricia Research – Centre for Specialised Nutrition|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition |
|- Brief summary||In this study infant formula containing a new fat blend is compared with the same infant formula containing the standard fat blend. |
The main parameter being studied is growth. Furthermore, gastrointestinal tolerance and safety are studied. The results are also compared to a breastfeeding reference group.
The infants will be included in the study until they are 35 days of age, study product intake will be until they are 4 months of age. There will be a follow-up period of two weeks after last product intake. Subsequently, subjects will be asked if they are willing to participate in an optional extension visit at 12 months of age.
During the intervention period, parents will be asked to fill in a diary with information on some of the parameters, and a questionnaire. Furthermore, they will be asked to collect a stool sample 2 to 3 times during the study. Voluntary blood draw can be taken at 3 and 12 months of age.
|- Main changes (audit trail)||15-okt-2014: Changes: |
- Inclusion criterium 2: addition of "with a minimum number of formula fed infants ≤ 14 days"
- Change of secondary outcomes in to: "1. To investigate equivalence of other growth parameters until the age of 17 weeks. 2. To assess gastrointestinal tolerance and safety until the age of 17 weeks. 3.To investigate efficacy in weight gain at 12 months"
- Addition of extra timepoint: "V6 (12 months)"
|- RECORD||2-nov-2012 - 25-okt-2014|