Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT02254460
Eligibility Criteria:
Inclusion Criteria:
* Demonstrates understanding of the study and willingness to participate as evidenced by participants' parents and/or legal guardian's voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form
* Participant belonging to middle socio-economic background as per modified Kuppuswamy scale
* Good general and mental health with, in the opinion of the investigator or medically qualified designee
* Child residing in the peri-urban areas of Bangalore city
* Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.
Exclusion Criteria:
* Children in Care (CiC)
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
* Participants with severe anaemia (Haemoglobin \< 8g %) as determined by laboratory results
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
* Recent history (3 months) of serious infections, injuries and/ or surgeries
* Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week) in last 6 months prior to screening visit
* Use of any prescription medications within 15 days prior to screening and throughout the entire duration of the study
* Recent history (within the last 1 year) of alcohol or other substance abuse.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
10 Years
Study:
NCT02254460
Study Brief:
Protocol Section:
NCT02254460