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:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT04413604
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent has been obtained from the parent.
* Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
* Child is age 12 - 32 months at enrolment.
* Child is no longer being breastfed (neither exclusively nor partially)
* Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
Exclusion Criteria:
* Child has consumed micronutrient supplements or micronutrient fortified foods or beverages in amounts greater than the thresholds below:
1. Micronutrient supplements (except for vitamin A): zero in the past 4 weeks
2. Micronutrient-fortified foods or beverages: zero servings in the past 2 weeks
* Chronic infectious illness, helminthiasis, or other acute disease/disorder potentially affecting feeding or growth (mild infectious illness, such as acute viral rhinopharyngitis, is acceptable).
* Any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g. short bowel syndrome) potentially affecting feeding, growth, or nutrient absorption.
* Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin \< 100 g/L based on screening assessment, rickets based on physical exam).
* Known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that affect diet.
* Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded.
* Weight-for-age value \< -2 or \> 2 standard deviations from the WHO(world health organization) Child Growth Standards median at enrollment.
* Height-for-age \< -2 or \> 2 standard deviations from the WHO(world health organization) Child Growth Standards median at enrollment.
* Child has participated in another clinical trial within 4 weeks prior to enrollment.
* Child of any investigational site staff member or Nestle employee directly involved in the conduct of the trial.
* Other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
32 Months
Study:
NCT04413604
Study Brief:
Protocol Section:
NCT04413604