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Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy — GRITO-14  

Cow's Milk Allergy Clinical Trial

Official title:
Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy

Clinical Trial Summary

This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).

Clinical Trial Description

The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02405923
Study type Interventional
Source Laboratorios Ordesa
Contact
Status Terminated
Phase N/A
Start date July 1, 2014
Completion date April 11, 2019
View Details
See also
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