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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.

Randomized control trial to assess the efficacy of a school snack with or without micronutrient fortification to promote vitamin B12 status in primary school children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017075
Enrollment
102
Registered
2019-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: 8g legume based protein product with micronutrients: 8g legume based protein product with micronutrients one time per day for 3 months. Control Intervention1: 8g legume based protein pr

Sponsors

Mars International India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1.vitamin B12 status. 2.Intestinal microbiota stool sampleTimepoint: Three times during the study. 1. Baseline i.e before start of intervention administration. 2.1 month post start of intervention. 3.During End line i.e after the last day of intervention administration.—

Secondary

MeasureTime frame
1.Cognitive functions test. 2.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference. 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.—

Countries

India

Contacts

Public ContactDr Maria Pauline

St. Johns National Academy of health sciences

mariapaulinejoe@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026