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Clinical Trials/CTRI/2019/01/017075
CTRI/2019/01/017075
Not yet recruiting
未知

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

Mars International India Private Limited0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Mars International India Private Limited
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Mars International India Private Limited

Eligibility 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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