Nutritional Deficiency Clinical Trial
— GaGAOfficial title:
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
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 role in reducing the risk and incidence of nutrient deficiencies. However,
affordability of GUM is an issue.
In this project the effects are studied of different daily intakes of GUM on iron status,
growth, several other nutrient status parameters in blood and urine, cognitive development,
and the intestinal microbiome in Nigerian toddlers 1-3 years of age.
The project is a collaboration with the department of Paediatrics and Child health of the
Lagos State University College of Medicine in Lagos. The design is based on a three-arm, open
(partly blind: statistics, biochemical analyses), randomized intervention trial. Recruitment
will take place in Ijora-Badia community in Apapa-Iganmu Local Council Development Area
(LCDA) in Lagos. The three groups will be given a multi-micronutrient fortified growing-up
milk (PEAK), in amounts of 200, 400 or 600 ml per day during a period of 6 months. Primary
objective of this study is to reduce iron deficiency anemia. Based on this objective, in
total 150 children have to be included in this study.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | January 24, 2019 |
Est. primary completion date | September 8, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 3 Years |
Eligibility |
Inclusion Criteria: 1. Normal term birth (caesarean section excluded) 2. Boys and girls in the age range of 12 to 36 months at enrolment 3. Apparently healthy at screening (assessed with the use of a medical history record) 4. Hb =70 g/L and =109 g/L, according to WHO guidelines 27 5. Mild to moderate acute malnutrition (i.e. HAZ, WAZ <-1 SD and > -3 SD) 6. Parents and/or legal guardians are residents of Oshodi LGA 7. Parents and/or legal guardians do not plan to migrate during the study 8. Written informed consent from parents and/or legal guardians 9. Children able to consume a maximum of 96g (= 600 ml) of product per day Exclusion Criteria: 1. Severe anaemia (Hb<70 g/L) or normal Hb (Hb=110 g/L) 2. Severe acute malnutrition (HAZ, WAZ <-3 SD) requiring hospitalization 3. Chronic or severe illness requiring hospitalisation and/or special treatment 4. Recent medical history (past 3 months) of serious infections, injuries and/or surgeries 5. Any known allergies or intolerances to milk or milk ingredients 6. Predominantly breast-fed infants or toddlers 7. Consumption of any other fortified foods or supplements 8. Participation to other micronutrient supplementation programmes 9. Participation to any other nutritional study in the last 6 months 10. Participation to another clinical study or receipt of an investigational drug in the last 30 days 11. Indication that they are likely to move within the period of study intervention 12. Family members of employees of the Sponsor or the study site. 13. Use of any prescription medications prior to and/or during the study period for more than or equal to two weeks. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
FrieslandCampina WAMCO Nigeria PLC | Lagos State University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | intestinal microbiome | intestinal microbiome in a subpopulation of infants to explore the effect of 2-7 mg of Fe per day (provided as ferrous-sulfate) on the numbers of and changes in Enterobacteriaceae | 6 months | |
Primary | Iron deficiency anaemia | Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration | 6 Months | |
Secondary | Hematocrit | Hematocrit to substantiate the effect of iron supplementation on Hb | 6 months | |
Secondary | Ferritin | ferritin to substantiate the effect of iron supplementation on Hb concentration | 6 months | |
Secondary | plasma concentrations of specific inflammation markers (i.e. C-Reactive) | plasma concentrations of specific inflammation markers (i.e. C-Reactive) | 6 months | |
Secondary | Weight | Body weight for infants up to 24 months old | 6 months | |
Secondary | Serum concentrations of specific micronutrient status | Serum concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements. | 6 Months | |
Secondary | Parameters of cognitive development | Parameters of cognitive development such as Memory tests, attention tests,using screening version of the Bayley III Test for Children | 6 Months | |
Secondary | Recumbent length | Length in meters and standing height for toddlers from 24 to 36 months old | 6 months | |
Secondary | Plasma concentrations of specific micronutrient status | Plasma concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements. | 6 months | |
Secondary | Urine concentrations of specific micronutrient status | Urine concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements. | 6 Months |
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