A Randomized control trial on primary school children to assess the efficacy of a protein snack with or without micronutrient fortification to promote vitamin B12 status.
- Registration Number
- CTRI/2019/01/017075
- Lead Sponsor
- Mars International India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Consent
Understanding of the study and willingness to participate as evidenced by subjectâ??s parents and/or legal guardianâ??s voluntary written informed consent as well as written assent by the subject and has received a signed and dated copy of the informed consent form as well as the assent form.
2. Compliance
Understands and is willing, able and likely to comply with all study procedures and restrictions.
3. 20 % of students mildly stunted (height for age Z-scores between -2.0 and -2.9).
1. Allergy/Intolerance
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds)
2. Clinical Study/Experimental Medication
Participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit.
3. Recent history (3 months) of serious infections, injuries and/ or surgeries.
4.Children consuming other nutritional supplements and/ or health food drink on a regular basis in the last 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.vitamin B12 status. <br/ ><br>2.Intestinal microbiota stool sampleTimepoint: Three times during the study. 1. Baseline i.e before start of intervention administration. <br/ ><br>2.1 month post start of intervention. <br/ ><br>3.During End line i.e after the last day of intervention administration.
- Secondary Outcome Measures
Name Time Method 1.Cognitive functions test. <br/ ><br>2.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference. <br/ ><br>3. Muscle strength test.Timepoint: Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration.