The objective of this study is to investigate the effect of a micronutrient-fortified GUM given for 20 weeks on the iron and vitamin D status of healthy 12-36 month old children in comparison to the control product.
ID
Source
Brief title
Condition
- Iron and trace metal metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the change in serum SF
concentrations after 20 weeks of study product consumption.
Secondary outcome
Prevalence of ID and IDA after 20 weeks of study product consumption
- ID is defined as SF <12 µg/l.
- IDA is defined as blood haemoglobin (Hb) <110 g/l, combined with SF <12 µg/l.
- Biochemical assessments of vitamin D status: change from baseline in serum
25(OH)D concentrations after 20 weeks of study consumption
- Prevalence of vitamin D deficiency, defined as serum 25(OH)D <50 nmol/l,
after 20 weeks of study product consumption
- Change from baseline in iron status markers Hb, serum Transferrin Receptor
(sTfR), Mean Cell Volume (MCV), Reticulocyte Hemoglobin Content (CHr)
- Change from baseline in several biomarkers for micronutrients:
o Serum calcium concentrations (absorption affected by vitamin D)
o Serum phosphate concentrations (absorption affected by vitamin D)
o Serum vitamin C concentrations (involved in iron absorption)
o Serum folate concentrations
o Serum zinc concentrations
- Change from baseline in blood parathyroid hormone concentrations (involved in
vitamin D homeostasis)
- Change from baseline in fatty acid profiles
Background summary
Early childhood (1-3 years of age) is a time of nutritional transition.
Increased physical activity, dietary composition evolution (i.e. role of milk
and food in the diet), taste and texture exposure; all these changes translate
in different requirements in energy, macro- and micronutrients.
In a diet for young children, these requirements are not always optimally
covered, and imbalances
(excess and deficiencies) are observed. It is known that in young children
(12-36 months of age) the intake of iron and vitamin D are lower than
recommended. This low intake contributes to low levels of iron and vitamin D in
the blood. A low level of iron in the blood is associated with a higher risk of
the common blood disorder anaemia. Low blood vitamin D levels can lead to
problems with the bones and is associated with the development of other
diseases in the long run, such as diabetes and hypertension.
Study objective
The objective of this study is to investigate the effect of a
micronutrient-fortified GUM given for 20 weeks on the iron and vitamin D status
of healthy 12-36 month old children in comparison to the control product.
Study design
Randomised, double-blind, controlled, multi-country and multi-centre
intervention study.
Intervention
Young children are asked to drink daily 300 to 500ml micronutrient-fortified
Growing Up Milk (GUM) or Cow's milk for 20 weeks.
Study burden and risks
No know or potential risks are expected from the use of the study products.
Taking a blood sample is inconvenient and unpleasant for the young children.
Sometimes bruising can occur.
For the parents/guardians the time spending for filling out the diaries,
questionnaires and visiting the research location will be a burden.
Upssalalaan 12
Utrecht 3584 CT
NL
Upssalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
-Apparently healthy male and female subjects between 12 and 36 months of age
-Stable health status (i.e. being unknown with chronic or recent acute diseases) and expected to remain stable
-Familiar with and currently drinking milk products; expected study product intake of 300-500 ml per day
- Written informed consent from parents
Exclusion criteria
- Known infection during the last week or infection needing medical assistance or treatment during the last 2 weeks
- Any case of anaemia treated with pharmaceutical product in the last three months
- Any relevant congenital abnormality, chromosomal disorder or severe disease (such as tracheoesophageal fistula, tracheomalacia, major congenital heart disease, Down*s syndrome, HIV, cancer)
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required)
- Current use of anti-regurgitation, anti-reflux or laxative medication
- Known hemoglobinopathies or thalassaemia
- Blood transfusion received within the last 6 months
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41045.098.12 |