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

Completed

• Conditions: Iron-deficiency; Vitamine D-deficiency; 10022958

• Registration Number: NL-OMON40082
• Lead Sponsor: utricia Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 62

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter in this study is the change in serum SF<br /><br>concentrations after 20 weeks of study product consumption.<br /><br></p><br>