Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk

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.

Study Overview

• Status: Terminated
• Conditions: Nutritional Status; Child Nutrition Sciences
• Intervention / Treatment: Other: Young children's milk (1-<3)

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Indonesian Nutrition Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YCM Group (1- <3) Years old; 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks	Other: Young children's milk (1-<3); young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3.; Other Names: YCM
No Intervention: Observation Group (1-<3) Years old; Habitual diet, consume the same regular foods and drinks as the children would normally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Vitamin D and Iron status	measure blood vitamin D and Iron value	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Zinc status	measure blood Zinc value	16 weeks
Assess micronutrient intake	Using 24 hour dietary recall	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess other nutrient biomarkers	measure changes by blood measurement for CRP in mg/L	16 weeks
assess other nutrient biomarkers	measure changes by blood measurement for serum retinol in μmol/L	16 weeks
assess other nutrient biomarkers	measure changes by blood measurement for alpha(1)-acid glycoprotein in absolute value	16 weeks
assess muscular fitness	measure changes by blood measurement for serum niacin	16 weeks
assess muscular fitness	measure changes by blood measurement for plasma vitamin B6	16 weeks
assess child developmental milestones	measure Ages & Stages Questionnaires, Third Edition; Minimum 0, Maximum 60, higher scores indicate more positive outcomes	16 weeks
assess child developmental milestones	measure Ages & Stages Questionnaires: Social-Emotional, Second Edition, Minimum 0, Maximum 180, lower scores indicate more positive outcomes	16 weeks
assess bone mass index	measure the development of bone mass	16 weeks
assess muscular fitness	measure handgrip strength using a portable dynamometer	16 weeks
assess stool microbiota composition and metabolism and gut biomarkers	measure stool microbiota composition and metabolism, plus biomarkers of gut function (e.g., calprotectin, alpha-1 antitrypsin, albumin) and short-chain fatty acids.	16 weeks
assess genetic markers of vitamin D metabolism / status	measure genetic variants isolated from blood draw	baseline
assess gastrointestinal (GI) tolerance	measure changes in gut comfort level min 10, max 60. Lower score indicate more positive outcomes	16 weeks
assess YCM acceptability in children consuming GUM.	measure how well acceptable is YCM for interventional group, minimum score 5 max score 33. higher score indicate positive outcome	16 weeks
To monitor growth and development	Anthropometry Assessment based on BMI in (kg/m^2) by weight (Kilograms), height (Metres)	16 weeks
To monitor standard adverse events (AE)	safety assessment by monitoring the AEs linked with participation in study	16 weeks
To monitor absenteeism from day care or pre-school due to illness	safety assessment by monitoring the days of absenteeism linked with participation in study	16 weeks
To monitor concomitant medication (CM) reporting	safety assessment by monitoring the concomitant medication linked with participation in study	16 weeks

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Sudigdo Sastroasmoro, MD, Department of Child Health, Medical School, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19.08.INF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No