An interventional study of Fortified milk Powder in Malnutrition; Mild, Iron-deficiency Anemia and Nutritional Stunting, sponsored by FrieslandCampina WAMCO Nigeria PLC. Status unknown. Open to participants aged 1 Year to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by FrieslandCampina WAMCO Nigeria PLC · Not applicable, Interventional, and Treatment
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.
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.
1,278 studies on the registry are indexed under Malnutrition; 231 are open to participants now.
This study's planned enrollment of 150 is above the median of 118 across 844 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →This is the only study on the registry with FrieslandCampina WAMCO Nigeria PLC as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Toddlers will be allocated to the 200 ml group
Other: Fortified milk Powder
Toddlers will be allocated to the 400 ml group
Other: Fortified milk Powder
Toddlers will be allocated to the 600 ml
Other: Fortified milk Powder
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)
Iron deficiency anaemia
Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration
Time frame: 6 Months
Hematocrit
Hematocrit to substantiate the effect of iron supplementation on Hb
Time frame: 6 months
Ferritin
ferritin to substantiate the effect of iron supplementation on Hb concentration
Time frame: 6 months
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
Time frame: 6 months
Weight
Body weight for infants up to 24 months old
Time frame: 6 months
Serum concentrations of specific micronutrient status
Serum concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Time frame: 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
Time frame: 6 Months
Recumbent length
Length in meters and standing height for toddlers from 24 to 36 months old
Time frame: 6 months
Plasma concentrations of specific micronutrient status
Plasma concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Time frame: 6 months
Urine concentrations of specific micronutrient status
Urine concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Time frame: 6 Months
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
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Feb 2018; primary completion for Sep 2018, 7 months later.
Of 418 interventional studies with no phase under Malnutrition, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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