Effectiveness of Iron-Fortified Milk on Iron Status and Anemia in Young Children in Mexico

This study has been completed.
Sponsor:
Information provided by:
Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier:
NCT00508131
First received: July 26, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

Iron deficiency and anemia in infants and young children impair neurodevelopment. Efficacious interventions for reducing the prevalences of iron deficiency and anemia, under controlled conditions, are available. However, little information is published about the effectiveness of large-scale programs.

Objective. Assess the effectiveness on iron deficiency and anemia in young children of a large-scale program that provides iron fortified milk at a subsidized price to low income households. Design, Setting, and Sampling. A randomized effectiveness study in 12 milk distribution clusters randomly selected from 542 clusters in 4 States in Mexico. Selected clusters were randomly assigned to receive iron-fortified milk FM, N=7) or non-fortified milk (NFM, N=5). Over 95% program beneficiaries with children 12-30 mo of age in the 12 clusters (490 in FM and 275 in NFM) were enrolled in the FM and NFM interventions and participated in a baseline survey. 635 children (405 in FM and 230 in NFM) and 584 children (371 in FM and 213 in NFM) completed the 6 and 12-mo follow-up surveys, respectively. Intervention: A daily portion of FM contained 5.28 mg of iron, 48 mg of sodium ascorbate and other added micronutrients. The FM and NFM were distributed to beneficiaries at a subsidized price in Milk Distribution Centers in the 12 clusters.

Main outcome measures: Mild-to-moderate anemia (Hb: 90-109 g/L), mild anemia (Hb: 100-109 g/L), moderate anemia (Hb: 90-99 g/L),iron deficiency: Serum Ferritin (SF) <12 ug/L and soluble transferring receptors (sTfR) >6 mg/L.Serum Zinc deficiency (< 65ug/dL), and stunting (<2SD Height/Age.

Intervention effects at 6 and 12 moths were assessed using General Linear Mixed Models with three repeated measures.


Condition Intervention Phase
Anemia
Iron Deficiency
Stunting
Other: Whole Cows Milk
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • Anemia [ Time Frame: 12 months ]
  • Iron deficiency [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Zinc deficiency [ Time Frame: 12 months ]
  • Stunting [ Time Frame: 12 months ]

Enrollment: 798
Study Start Date: May 2003
Study Completion Date: July 2004
Arms Assigned Interventions
Active Comparator: A
Milk fortified with, iron, zinc and vitamin C
Other: Whole Cows Milk
400 mL, administered as two 200 mL drinking episodes per day of either fortified or not fortified milk for 12 months.
Other Name: Leche LICONSA (Liconsa, Mexico)
Placebo Comparator: B
Milk not fortified
Other: Whole Cows Milk
400 mL, administered as two 200 mL drinking episodes per day of either fortified or not fortified milk for 12 months.
Other Name: Leche LICONSA (Liconsa, Mexico)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children 12-30 months of age who were beneficiaries of the program in the 12 milk distribution clusters

Exclusion Criteria:

  • Children with severe anemia (Hb concentrations < 90 g/L)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00508131

Locations
Mexico
Instituto Nacional de Salud Publica
Cuernavaca, Morelos, Mexico, 62508
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Investigators
Principal Investigator: Salvador Villalpando, M. D., Ph.D Instituto Nacional de Salud Publica, Mexico
Study Director: Teresa Shamah, MSc Instituto Nacional de Salud Publica, Mexico
Study Chair: Juan A Rivera, MSc, Ph.D. Instituto Nacional de Salud Publica, Mexico
  More Information

No publications provided by Instituto Nacional de Salud Publica, Mexico

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00508131     History of Changes
Other Study ID Numbers: 1408svillalp
Study First Received: July 26, 2007
Last Updated: July 26, 2007
Health Authority: Mexico: Ministry of Health

Keywords provided by Instituto Nacional de Salud Publica, Mexico:
Milk fortification
Effectivness evaluation
Iron deficiency anemia
Stunting
Zinc deficiency

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014