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Fortified Milk, Growth and Micronutrient Status in Mexican Toddlers (MilkGrowth)

NCT03397485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2018-01-16

No results posted yet for this study

Summary

The objective of the present study was to assess the effect of a growing-up milk on growth and micronutrient status in children 12 to 30 months of age.

The study was conducted in Cuernavaca, the state capital of Morelos, Mexico. The investigators included children who attended day-care centers. These day- care centers are part of a national government program which main objective is to support working mothers and those who intend to work and do not have access to a health service and are at risk of poverty. The study described herein is a randomized, parallel, double-blind, controlled trial by administration of growing up milk (GM) and fortified milk (FM).

Results showed a significant improvement in linear growth in both supplemented groups, with no statistical difference between treatments. By using an artificial, population-based comparison group, the investigators conclude that this improvement was attributable to the supplements.

Conditions

  • Undernutrition

Interventions

DIETARY_SUPPLEMENT

Growing milk

Intervention Milk powder was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Trained personnel prepared the milk according to the color-coding assigned to each child. Bottles were used to facilitate measuring in milliliters. Each bottle was weighted before and after preparing milk in a diet measuring scale (OHOUSE, model CS5000, capacity 5000gx2g).Each children received an individual bottle or cup with its own milk (240ml). Once each bottle or cup was prepared it was given to the child. After the child finished drinking the milk, leftovers were weighted and recorded.

DIETARY_SUPPLEMENT

Fortified milk

Intervention Milk powder was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Trained personnel prepared the milk according to the color-coding assigned to each child. Bottles were used to facilitate measuring in milliliters. Each bottle was weighted before and after preparing milk in a diet measuring scale (OHOUSE, model CS5000, capacity 5000gx2g).Each children received an individual bottle or cup with its own milk (240ml). Once each bottle or cup was prepared it was given to the child. After the child finished drinking the milk, leftovers were weighted and recorded.

Sponsors & Collaborators

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Mario E Flores Aldana, PhD · Instituto Nacional de Salud Publica, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2016-12-01
Completion
2016-12-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397485 on ClinicalTrials.gov