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A Randomised, double-blind, controlled trial to evaluate the effects of a micronutrient-fortified Growing Up Milk on the micro-nutrient status of young children

A Randomised, double-blind, controlled trial to evaluate the effects of a micronutrient-fortified Growing Up Milk on the micro-nutrient status of young children - ID(ea): Iron + vitamin D

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40082
Enrollment
62
Registered
2012-09-20
Start date
2012-10-29
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency Vitamine D-deficiency

Interventions

Young children are asked to drink daily 300 to 500ml micronutrient-fortified Growing Up Milk (GUM) or Cow's milk for 20 weeks.

Sponsors

Nutricia Research
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary outcome parameter in this study is the change in serum SF concentrations after 20 weeks of study product consumption.

Secondary

MeasureTime frame
Prevalence of ID and IDA after 20 weeks of study product consumption - ID is defined as SF

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)