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

Not Applicable

Terminated

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

• Registration Number: NCT04413604
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-04
• Study Start: 2021-10-22
• Primary Completion: 2022-05-24
• Status Verified: 2022-07
• Study Completion: 2022-07-20
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YCM Group (1- <3) Years old	Young children's milk (1-<3)	2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks

Primary Outcome Measures

Name	Time	Method
change in Vitamin D and Iron status	16 weeks	measure blood vitamin D and Iron value

Secondary Outcome Measures

Name	Time	Method
change in Zinc status	16 weeks	measure blood Zinc value
Assess micronutrient intake	16 weeks	Using 24 hour dietary recall

Trial Locations

Locations (1)

Indonesian Nutrition Association; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia