Clinical trial NCT04413604: Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk
Official title: Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nutritional Status
Child Nutrition Sciences
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates changes in Vitamin D, Zinc, and Iron status of children consuming 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks compared to children of the same age who consume their habitual pattern of beverage intake for the same duration.

Detailed description: The overall purpose of the study is to demonstrate improved vitamin D status and/or improved iron status of children ages 1 to 3 years who are consuming the investigational (test) young children's milk (YCM) compared to children consuming their habitual pattern of beverage intake (milk and non-milk beverages). This is based on previous study findings that (i) the toddler's diet, in reality, is often not optimal, putting toddlers at risk of insufficient intakes of several nutrients, and (ii) consuming YCM supplemented with these nutrients might provide optimal intakes of these nutrients.

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.

Primary outcomes:
measure: change in Vitamin D and Iron status
timeFrame: 16 weeks
Secondary outcomes:
measure: change in Zinc status
timeFrame: 16 weeks
measure: Assess micronutrient intake
timeFrame: 16 weeks
Other outcomes:
measure: assess other nutrient biomarkers
timeFrame: 16 weeks
measure: assess other nutrient biomarkers
timeFrame: 16 weeks
measure: assess other nutrient biomarkers
timeFrame: 16 weeks
measure: assess muscular fitness
timeFrame: 16 weeks
measure: assess muscular fitness
timeFrame: 16 weeks
measure: assess child developmental milestones
timeFrame: 16 weeks
measure: assess child developmental milestones
timeFrame: 16 weeks
measure: assess bone mass index
timeFrame: 16 weeks
measure: assess muscular fitness
timeFrame: 16 weeks
measure: assess stool microbiota composition and metabolism and gut biomarkers
timeFrame: 16 weeks
measure: assess genetic markers of vitamin D metabolism / status
timeFrame: baseline
measure: assess gastrointestinal (GI) tolerance
timeFrame: 16 weeks
measure: assess YCM acceptability in children consuming GUM.
timeFrame: 16 weeks
measure: To monitor growth and development
timeFrame: 16 weeks
measure: To monitor standard adverse events (AE)
timeFrame: 16 weeks
measure: To monitor absenteeism from day care or pre-school due to illness
timeFrame: 16 weeks
measure: To monitor concomitant medication (CM) reporting
timeFrame: 16 weeks
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Indonesian Nutrition Association
state: Jakarta
Study officials:
affiliation: Department of Child Health, Medical School, University of Indonesia
name: Sudigdo Sastroasmoro, MD
role: PRINCIPAL_INVESTIGATOR
References: