Clinical trial · Interventional
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Enterobacteriaceae Infections | — | UNRESOLVED | — |
| Iron-deficiency Anemia | — | UNRESOLVED | — |
| Malnutrition; Mild | — | UNRESOLVED | — |
| Nutritional Deficiency | — | UNRESOLVED | — |
| Nutritional Stunting | — | UNRESOLVED | — |
| Nutritional Wasting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fortified milk Powder | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- 200ml
- description
- Toddlers will be allocated to the 200 ml group
- interventionNames
- Other: Fortified milk Powder
- type
- OTHER
- label
- 400ml
- description
- Toddlers will be allocated to the 400 ml group
- interventionNames
- Other: Fortified milk Powder
- type
- OTHER
- label
- 600ml
- description
- Toddlers will be allocated to the 600 ml
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 3 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSenbanjo IO, Owolabi AJ, Oshikoya KA, Hageman JHJ, Adeniyi Y, Samuel F, Melse-Boonstra A, Schaafsma A. Effect of a Fortified Dairy-Based Drink on Micronutrient Status, Growth, and Cognitive Development of Nigerian Toddlers- A Dose-Response Study. Front Nutr. 2022 Apr 27;9:864856. doi: 10.3389/fnut.2022.864856. eCollection 2022. PMID 35571933