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

Nutritional Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04413604
• Other study ID #: 19.08.INF
• Status: Terminated
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: July 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: July 20, 2022
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 32 Months

Eligibility

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.

Related Conditions & MeSH terms

• Child Nutrition Sciences
• Nutritional Status

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Indonesian Nutrition Association	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	assess other nutrient biomarkers	measure changes by blood measurement for CRP in mg/L	16 weeks
Other	assess other nutrient biomarkers	measure changes by blood measurement for serum retinol in µmol/L	16 weeks
Other	assess other nutrient biomarkers	measure changes by blood measurement for alpha(1)-acid glycoprotein in absolute value	16 weeks
Other	assess muscular fitness	measure changes by blood measurement for serum niacin	16 weeks
Other	assess muscular fitness	measure changes by blood measurement for plasma vitamin B6	16 weeks
Other	assess child developmental milestones	measure Ages & Stages Questionnaires, Third Edition; Minimum 0, Maximum 60, higher scores indicate more positive outcomes	16 weeks
Other	assess child developmental milestones	measure Ages & Stages Questionnaires: Social-Emotional, Second Edition, Minimum 0, Maximum 180, lower scores indicate more positive outcomes	16 weeks
Other	assess bone mass index	measure the development of bone mass	16 weeks
Other	assess muscular fitness	measure handgrip strength using a portable dynamometer	16 weeks
Other	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
Other	assess genetic markers of vitamin D metabolism / status	measure genetic variants isolated from blood draw	baseline
Other	assess gastrointestinal (GI) tolerance	measure changes in gut comfort level min 10, max 60. Lower score indicate more positive outcomes	16 weeks
Other	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
Other	To monitor growth and development	Anthropometry Assessment based on BMI in (kg/m^2) by weight (Kilograms), height (Metres)	16 weeks
Other	To monitor standard adverse events (AE)	safety assessment by monitoring the AEs linked with participation in study	16 weeks
Other	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
Other	To monitor concomitant medication (CM) reporting	safety assessment by monitoring the concomitant medication linked with participation in study	16 weeks
Primary	change in Vitamin D and Iron status	measure blood vitamin D and Iron value	16 weeks
Secondary	change in Zinc status	measure blood Zinc value	16 weeks
Secondary	Assess micronutrient intake	Using 24 hour dietary recall	16 weeks