Effectiveness of Iron-Fortified Milk on Iron Status and Anemia in Young Children in Mexico
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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 |
- Anemia [ Time Frame: 12 months ]
- Iron deficiency [ Time Frame: 12 months ]
- 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 |
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| Mexico | |
| Instituto Nacional de Salud Publica | |
| Cuernavaca, Morelos, Mexico, 62508 | |
| 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 June 18, 2013