Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Wit… (NCT05440604) | Clinical Trial Compass
CompletedNot Applicable
Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk
Philippines112 participantsStarted 2022-06-23
Plain-language summary
This study compares the status of key micronutrients (vitamins A, C, D, E, and zinc) in young children given investigational fortified milk versus young children consuming their habitual pattern of beverage intake (milk and non-milk beverages).
Who can participate
Age range
36 Months – 54 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
. Child's parent(s)/guardian is/are of legal age of consent, must understand the informed consent and other study documents, and is/are willing and able to fulfill the requirements of the study protocol
. Age 3 years old to 4 years old and 6 months at enrolment
. Healthy at birth, singleton, full-term gestational birth (37-42 completed weeks of gestation), with a birth weight of 2.5 kg to 3.9 kg
. At the time of enrolment, the participant's weight-for-age, height-for-age, weight-for-height, BMI z-score should be within -2 to +1
. At the time of enrolment, the participant is in good health (no history of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the child to ingest food, the normal growth and development of the child, or the evaluation of the infant; acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot \& mouth disease at time of enrolment is permitted) as determined by physical history, physical exam and judgement by the investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study
Exclusion criteria
. Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures
. 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 / lactose intolerance /allergy or severe food allergies that impact diet
. Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age
. Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc
. Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures