Malnutrition; MildGaGANCT03411590
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
A study testing Fortified milk Powder in people with Malnutrition; Mild and Iron-deficiency Anemia, run by FrieslandCampina WAMCO Nigeria PLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting
- What is being tested?
- Fortified milk Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2018to 24 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting, Nutritional Wasting, Nutritional Deficiency, Enterobacteriaceae Infections
- Being tested
- Fortified milk Powder
- Medical subject headings
- Malnutrition, Lymphoma, Follicular, Anemia, Iron-Deficiency, Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified milk PowderOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 200ml | Other | Toddlers will be allocated to the 200 ml group Receives: Other: Fortified milk Powder |
| 400ml | Other | Toddlers will be allocated to the 400 ml group Receives: Other: Fortified milk Powder |
| 600ml | Other | Toddlers will be allocated to the 600 ml Receives: Other: Fortified milk Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron deficiency anaemia
Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration
Measured: 6 Months
Secondary outcomes (9)
Hematocrit
Hematocrit to substantiate the effect of iron supplementation on Hb
Measured: 6 months
Ferritin
ferritin to substantiate the effect of iron supplementation on Hb concentration
Measured: 6 months
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
Measured: 6 months
Weight
Body weight for infants up to 24 months old
Measured: 6 months
Serum concentrations of specific micronutrient status
Serum concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Measured: 6 Months
Parameters of cognitive development
Parameters of cognitive development such as Memory tests, attention tests,using screening version of the Bayley III Test for Children
Measured: 6 Months
Recumbent length
Length in meters and standing height for toddlers from 24 to 36 months old
Measured: 6 months
Plasma concentrations of specific micronutrient status
Plasma concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Measured: 6 months
Urine concentrations of specific micronutrient status
Urine concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start5 Feb 2018 (estimated)
- Primary completion8 Sep 2018 (estimated)
- Study completion24 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition; MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina WAMCO Nigeria PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lagos State University
- Responsible party
- Sponsor
- Investigators
- Idowu O Senbanjo, MBBS, Principal investigator, LAGOS STATE UNIVERSITY COLLEGE OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411590
- Sponsor's protocol ID
- 2017-GAGA-GND
- Acronym
- GaGA
- Status last verified
- Jan 2018
- First submitted
- 11 Dec 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35571933
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
- ClinicalTrials.gov ID
- NCT03411590
- Acronym / sponsor ID
- GaGA / 2017-GAGA-GND
- Conditions
- Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting, Nutritional Wasting, Nutritional Deficiency, Enterobacteriaceae Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- FrieslandCampina WAMCO Nigeria PLCIndustry (pharma, biotech, devices)
- Collaborators
- Lagos State University
- Study start
- 5 Feb 2018 (estimated)
- Primary completion
- 8 Sep 2018 (estimated)
- Study completion
- 24 Jan 2019 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200ml | Other | Other: Fortified milk PowderToddlers will be allocated to the 200 ml group |
| 400ml | Other | Other: Fortified milk PowderToddlers will be allocated to the 400 ml group |
| 600ml | Other | Other: Fortified milk PowderToddlers will be allocated to the 600 ml |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortified milk PowderToddlers 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) | Other | 200ml, 400ml, 600ml |
Primary outcome
Iron deficiency anaemia
Time frame: 6 Months
Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration
9 secondary outcomes
Hematocrit
Time frame: 6 months
Ferritin
Time frame: 6 months
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
Time frame: 6 months
Weight
Time frame: 6 months
Serum concentrations of specific micronutrient status
Time frame: 6 Months
Parameters of cognitive development
Time frame: 6 Months
Recumbent length
Time frame: 6 months
Plasma concentrations of specific micronutrient status
Time frame: 6 months
Urine concentrations of specific micronutrient status
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Derived from this study: PubMed 35571933Senbanjo 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idowu O Senbanjo, MBBS principal investigator
LAGOS STATE UNIVERSITY COLLEGE OF MEDICINE
Questions about this trial
What is this clinical trial studying?
A study testing Fortified milk Powder in people with Malnutrition; Mild and Iron-deficiency Anemia, run by FrieslandCampina WAMCO Nigeria PLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adedotun J Owolabi, MSc (+23401271500 ext. 2661, adedotun.owolabi@frieslandcampina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron deficiency anaemia (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.