MedTrace Logo

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

NCT00508131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 798

Last updated 2007-07-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Salvador Villalpando, M. D., Ph.D · Instituto Nacional de Salud Publica, Mexico

  • Teresa Shamah, MSc · Instituto Nacional de Salud Publica, Mexico

  • Juan A Rivera, MSc, Ph.D. · Instituto Nacional de Salud Publica, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2003-05-31
Completion
2004-07-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT00508131 on ClinicalTrials.gov