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

NCT04413604 | Terminated DMC

• 1 other identifier: 19.08.INF
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Status; Child Nutrition Sciences

Outcome Measures

Primary Outcomes (1)

• change in Vitamin D and Iron status

  measure blood vitamin D and Iron value

  16 weeks

Secondary Outcomes (2)

• change in Zinc status

  16 weeks

• Assess micronutrient intake

  16 weeks

Other Outcomes (17)

• assess other nutrient biomarkers

  16 weeks

• assess other nutrient biomarkers

  16 weeks

• assess other nutrient biomarkers

  16 weeks

Study Arms (2)

YCM Group (1- <3) Years old

EXPERIMENTAL

2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks

Other: Young children's milk (1-<3)

Observation Group (1-<3) Years old

NO INTERVENTION

Habitual diet, consume the same regular foods and drinks as the children would normally

Interventions

Young children's milk (1-<3) OTHER

young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3.

Also known as: YCM

YCM Group (1- <3) Years old

Eligibility Criteria

• Age: 12 Months - 32 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Child has consumed micronutrient supplements or micronutrient fortified foods or beverages in amounts greater than the thresholds below:
• Micronutrient supplements (except for vitamin A): zero in the past 4 weeks
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Indonesian Nutrition Association

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Officials

• Sudigdo Sastroasmoro, MD

  Department of Child Health, Medical School, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: June 4, 2020
• Study Start: October 22, 2021
• Primary Completion: May 24, 2022
• Study Completion: July 20, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

ID (1)