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

NCT03397485 | Completed DMC

• 1 other identifier: 0114-6631
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Change in weight from baseline at 4 months

  Weight was taken at baseline and 16wks and transformed to Z scores by using the 2006 World Health Organization (WHO) reference standards.

  4 months

• Change in length of anthropometrics from baseline at 4 months

  Length was taken at baseline and 16wks and transformed to Z scores by using the 2006 World Health Organization (WHO) reference standards.

  4 months

• Change head circumference of anthropometrics from baseline at 4 months

  Head circumference was taken at baseline and 16wks and transformed to Z scores by using the 2006 World Health Organization (WHO) reference standards.

  4 months

Secondary Outcomes (11)

• Change in DHA

  4 months

• Change in EPA

  4 months

• Change in Arachidonic acid

  4 months

• Change in Oleic acid

  4 months

• Change in Linoleic acid

  4 months

Study Arms (2)

Growing Milk

EXPERIMENTAL

Experimental Fortified milk has energy from fatty acids, protein and carbohydrates. This milk has probiotics and essential micronutrients such as Zn, Fe, vitamins ( A, D, E, K, C and B complex), selenium and Copper among others. Intervention Milk powder was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Bottles were used to facilitate measuring in milliliters and were weighted before and after preparing milk in a diet measuring scale. Mothers were given the amount of milk necessary to prepare 480 ml per day during the weekend.

Dietary Supplement: Growing milk

Fortified Milk

ACTIVE COMPARATOR

Fortified milk has no energy from fatty acids nor micronutrients such as vitamin B12, Selenium and Copper. This milk was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Bottles were used to facilitate measuring in milliliters and were weighted before and after preparing milk in a diet measuring scale. Mothers were given the amount of milk necessary to prepare 480 ml per day during the weekend.

Dietary Supplement: Fortified milk

Interventions

Growing milk DIETARY_SUPPLEMENT

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.

Growing Milk

Fortified milk DIETARY_SUPPLEMENT

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.

Fortified Milk

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who attended day-care centers
• Children whose parents accepted to participate in the study.

You may not qualify if:

• Children who were breastfed at the time of the study
• Children receiving multiple micronutrient supplementation
• Children with capillary hemoglobin \<9.0g/dl, at baseline
• Children clinically sick

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead
• Mead Johnson Nutrition: collaborator

Study Sites (1)

Insituto Nacional de Salud Publica

Cuernavaca, Morelos, 62100, Mexico

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mario E Flores Aldana, PhD

  Instituto Nacional de Salud Publica, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Sciences Reasercher

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: January 12, 2018
• Study Start: January 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)