Status:
UNKNOWN
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
Lead Sponsor:
FrieslandCampina WAMCO Nigeria PLC
Collaborating Sponsors:
Lagos State University
Conditions:
Malnutrition; Mild
Iron-deficiency Anemia
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
It is well known than an important part of Nigerian children from the lower social economic class have nutrient deficiencies. Fortified products, such as growing up milks (GUM), may play an important ...
Detailed Description
The present study will be a three-arm, open (partly blind) blind, randomized intervention trial in Nigerian children (12-36 months of age). Recruitment will take place in Ijora-Badia community in Apap...
Eligibility Criteria
Inclusion
- Normal term birth (caesarean section excluded)
- Boys and girls in the age range of 12 to 36 months at enrolment
- Apparently healthy at screening (assessed with the use of a medical history record)
- Hb ≥70 g/L and ≤109 g/L, according to WHO guidelines 27
- Mild to moderate acute malnutrition (i.e. HAZ, WAZ \<-1 SD and \> -3 SD)
- Parents and/or legal guardians are residents of Oshodi LGA
- Parents and/or legal guardians do not plan to migrate during the study
- Written informed consent from parents and/or legal guardians
- Children able to consume a maximum of 96g (= 600 ml) of product per day
Exclusion
- Severe anaemia (Hb\<70 g/L) or normal Hb (Hb≥110 g/L)
- Severe acute malnutrition (HAZ, WAZ \<-3 SD) requiring hospitalization
- Chronic or severe illness requiring hospitalisation and/or special treatment
- Recent medical history (past 3 months) of serious infections, injuries and/or surgeries
- Any known allergies or intolerances to milk or milk ingredients
- Predominantly breast-fed infants or toddlers
- Consumption of any other fortified foods or supplements
- Participation to other micronutrient supplementation programmes
- Participation to any other nutritional study in the last 6 months
- Participation to another clinical study or receipt of an investigational drug in the last 30 days
- Indication that they are likely to move within the period of study intervention
- Family members of employees of the Sponsor or the study site.
- Use of any prescription medications prior to and/or during the study period for more than or equal to two weeks.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 24 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03411590
Start Date
February 5 2018
End Date
January 24 2019
Last Update
January 29 2018
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