Randomised, double-blind, controlled, multi-country and multi-centre intervention study.
Completed
- Conditions
- - Healthy toddlers, 18 - 36 month old- growing up milk- Vitamin D level- Iron level
- Registration Number
- NL-OMON29128
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 288
Inclusion Criteria
1. Apparently healthy male and female subjects between 12 and 36 months of age;
2. Stable health status (i.e. being unknown with chronic or recent acute diseases) and expected to remain stable;
Exclusion Criteria
1. Known infection during the last week or infection needing medical assistance or treatment during the last 2 weeks;
2. Any case of anaemia treated with pharmaceutical product in the last three months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter in this study is the change in serum SF concentrations after 20 weeks of study product consumption.
- Secondary Outcome Measures
Name Time Method 1. Prevalence of ID and IDA:<br /><br>A. ID is defined as SF <12 µg/l;<br /><br>B. IDA is defined as blood haemoglobin (Hb) <110 g/l, combined with SF <12 µg/l.<br /><br>2. Biochemical assessments of vitamin D status: change from baseline in serum 25(OH)D concentrations;<br /><br>3. Prevalence of vitamin D deficiency, defined as serum 25(OH)D < 50 nmol/l.