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The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers (GaGA)

Primary Purpose

Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fortified milk Powder
Sponsored by
FrieslandCampina WAMCO Nigeria PLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition; Mild

Eligibility Criteria

1 Year - 3 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    200ml

    400ml

    600ml

    Arm Description

    Toddlers will be allocated to the 200 ml group

    Toddlers will be allocated to the 400 ml group

    Toddlers will be allocated to the 600 ml

    Outcomes

    Primary Outcome Measures

    Iron deficiency anaemia
    Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration

    Secondary Outcome Measures

    Hematocrit
    Hematocrit to substantiate the effect of iron supplementation on Hb
    Ferritin
    ferritin to substantiate the effect of iron supplementation on Hb concentration
    plasma concentrations of specific inflammation markers (i.e. C-Reactive)
    plasma concentrations of specific inflammation markers (i.e. C-Reactive)
    Weight
    Body weight for infants up to 24 months old
    Serum concentrations of specific micronutrient status
    Serum concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
    Parameters of cognitive development
    Parameters of cognitive development such as Memory tests, attention tests,using screening version of the Bayley III Test for Children
    Recumbent length
    Length in meters and standing height for toddlers from 24 to 36 months old
    Plasma concentrations of specific micronutrient status
    Plasma concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
    Urine concentrations of specific micronutrient status
    Urine concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.

    Full Information

    First Posted
    December 11, 2017
    Last Updated
    January 26, 2018
    Sponsor
    FrieslandCampina WAMCO Nigeria PLC
    Collaborators
    Lagos State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03411590
    Brief Title
    The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
    Acronym
    GaGA
    Official Title
    The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 5, 2018 (Anticipated)
    Primary Completion Date
    September 8, 2018 (Anticipated)
    Study Completion Date
    January 24, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    FrieslandCampina WAMCO Nigeria PLC
    Collaborators
    Lagos State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.
    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 Apapa-Iganmu Local Council Development Area (LCDA), Lagos, South-West Nigeria. Ijora-Badia community has the highest burden of under-nutrition; In addition, it consists predominantly of low to middle socioeconomic status population, which is nationally representative, thus making it an ideal choice for this study. All families that are permanent residents of Ijora-Badia and have children aged 12-36 months will be invited to participate in the study. Before screening and recruitment will take place, parents or legal guardians of all potential candidates (toddlers) will be fully informed about the study, requirements and procedures. This means that at the day of screening, recruitment and enrolment, 10-20 children per day, fulfilling inclusion criteria, will be directly assigned to one of the three study groups when a written informed consent is obtained from the parents or legal guardians. At the day of screening and recruitment, mothers will be required to bring their child to the clinic. At this initial screening toddlers will be evaluated to assess their eligibility for participation to the study according to the inclusion and exclusion criteria (i.e. anthropometric measurements, blood collection for the assessment of haemoglobin levels and information collected by parents). Those toddlers meeting all inclusion criteria will be considered as eligible and will be randomised to one of the three study groups. Prior to the initiation of the intervention, all eligible study participants will be dewormed (medicine, brand, dosage). Baseline measurements will take place that same day, and after 6 months of intervention: anthropometric measurement, a cognitive test (30 minutes), and venous blood sampling (8 ml). For food and nutrient intake indices, and faecal sampling, a proper planning will be made, to be sure that it takes place within 3 days following baseline measurements. The three groups will be given a multi-micronutrient fortified growing-up milk, in amounts of 200, 400 or 600 ml per day. In case of 400 and 600 ml, the portions (200 ml each) will be spread during the day. Airtight packed portions of milk powder sachets will be delivered weekly at the families by field monitors who also provide instructions for use as well as collect empty sachets for a compliance check. Consumption of test product will start as soon as all baseline examinations and samples have been completed and collected, and will last for 6 months. Prior to the initiation of the screening and recruitment phase, the study protocol will have to be approved by the Lagos State University Teaching Hospital Research/Ethics Committee, and has to be registered in an acknowledged trial register.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting, Nutritional Wasting, Nutritional Deficiency, Enterobacteriaceae Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    200ml
    Arm Type
    Other
    Arm Description
    Toddlers will be allocated to the 200 ml group
    Arm Title
    400ml
    Arm Type
    Other
    Arm Description
    Toddlers will be allocated to the 400 ml group
    Arm Title
    600ml
    Arm Type
    Other
    Arm Description
    Toddlers will be allocated to the 600 ml
    Intervention Type
    Other
    Intervention Name(s)
    Fortified milk Powder
    Intervention Description
    Toddlers will be allocated to the 200 ml group and will receive on a daily basis 32g of growing up milk powder respectively, in doses of 16 g, which can be reconstituted with 180 ml water to a final volume of about 200 ml of milk. The intervention period will last for 6 months. For the 200 ml test group, this translates into 32 g of growing up milk powder supply as one dose per day (in the morning)
    Primary Outcome Measure Information:
    Title
    Iron deficiency anaemia
    Description
    Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    Hematocrit
    Description
    Hematocrit to substantiate the effect of iron supplementation on Hb
    Time Frame
    6 months
    Title
    Ferritin
    Description
    ferritin to substantiate the effect of iron supplementation on Hb concentration
    Time Frame
    6 months
    Title
    plasma concentrations of specific inflammation markers (i.e. C-Reactive)
    Description
    plasma concentrations of specific inflammation markers (i.e. C-Reactive)
    Time Frame
    6 months
    Title
    Weight
    Description
    Body weight for infants up to 24 months old
    Time Frame
    6 months
    Title
    Serum concentrations of specific micronutrient status
    Description
    Serum concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
    Time Frame
    6 Months
    Title
    Parameters of cognitive development
    Description
    Parameters of cognitive development such as Memory tests, attention tests,using screening version of the Bayley III Test for Children
    Time Frame
    6 Months
    Title
    Recumbent length
    Description
    Length in meters and standing height for toddlers from 24 to 36 months old
    Time Frame
    6 months
    Title
    Plasma concentrations of specific micronutrient status
    Description
    Plasma concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
    Time Frame
    6 months
    Title
    Urine concentrations of specific micronutrient status
    Description
    Urine concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
    Time Frame
    6 Months
    Other Pre-specified Outcome Measures:
    Title
    intestinal microbiome
    Description
    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
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adedotun J Owolabi, MSc
    Phone
    +23401271500
    Ext
    2661
    Email
    adedotun.owolabi@frieslandcampina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne Schaafsma, PhD
    Phone
    +34582992424
    Email
    anne.schafsma@frieslandcampina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Idowu O Senbanjo, MBBS
    Organizational Affiliation
    LAGOS STATE UNIVERSITY COLLEGE OF MEDICINE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35571933
    Citation
    Senbanjo 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.
    Results Reference
    derived

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    The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers

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