EVALUATION OF THE SAFETY AND EFFICACY OF A FISH PURIFIED PROTEIN (FPI), IN THE NUTRITION OF CHILDREN UNDER 36 MONTHS OF AGE
- Registration Number
- PER-099-11
- Lead Sponsor
- FUNDACION CAYETANO HEREDIA,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 0
1. CHILDREN BETWEEN 6 MONTHS AND 36 MONTHS OF AGE.
2. CHILDREN REGULARLY PARTICIPATING (> 4 TIMES A WEEK) IN THE CHILDREN´S HOME OR DINING ROOM OF THE DISTRICTS OF INDEPENDENCIA, COMAS AND SAN MARTIN DE PORRES.
3. CHILDREN WITH AT LEAST 2 MEALS IN THE CHILDREN´S HOME OR DINING ROOM (BREAKFAST AND LUNCH OR LUNCH AND DINNER), REPRESENTING AT LEAST 50% OF DAILY CALORIE INTAKE REQUIRED.
1. CHILDREN WITH UNDERLYING CONDITIONS DEEPLY AFFECTING GROWTH AND DEVELOPMENT (SEVERE CONGENITAL ABNORMALITIES, SEVERE CHRONIC DISEASES).
2. CHILDREN WITH FAMILY HISTORY OF SEVERE FOOD ALLERGY OR FAMILY HISTORY (PARENTS OR BROTHERS) OF ALLERGY TO FISH.
3. CHILDREN THAT ACCORDING TO THE INVESTIGATOR CRITERIA HAVE NOT THE POSSIBILITY TO COMPLETE THE 6 MONTHS FOLLOW UP OF THE STUDY (CHILDREN ARE TEMPORARILY IN THE DINING ROOM AND WILL MOVE TO ANOTHER DISTRICT OR TRAVEL TO A PROVINCE).
4. CHILDREN WHOSE PARENTS DO NOT ACCEPT TO PARTICIPATE.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method