Trials / Withdrawn
WithdrawnNCT00548106
Safety Study of Infant Formula With Partially Hydrolized Whey
Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Soroka University Medical Center · Academic / Other
- Sex
- All
- Age
- 1 Day – 30 Days
- Healthy volunteers
- Not accepted
Summary
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving. The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age. There will be two study groups, each receiving one of the following formulas: 1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot. 2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
Detailed description
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving. The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age. There will be two study groups, each receiving one of the following formulas: 1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot. 2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | partially hydrolyzed whey | Total infant feeding by study formula. |
| DIETARY_SUPPLEMENT | Nan HA | Total infant diet by study formula. |
Timeline
- First posted
- 2007-10-23
- Last updated
- 2012-06-14
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00548106. Inclusion in this directory is not an endorsement.