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Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children

Primary Purpose

Anemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron
Multiple micronutrients supplement
micronutrient fortified porridge powder
Iron and ascorbic acid fortified water
Iron plus folic acid supplement
Sponsored by
Universidad Autonoma de Queretaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Iron, Children, Micronutrients

Eligibility Criteria

6 Months - 42 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hemoglobin less than 11.7g/dL and above 7.0g/dL

Exclusion Criteria:

  • Breastfeeding
  • Chronic gastroenteritis
  • Any other severe illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Anemic children

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2009
    Last Updated
    January 13, 2009
    Sponsor
    Universidad Autonoma de Queretaro
    Collaborators
    Procter and Gamble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00822380
    Brief Title
    Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children
    Official Title
    Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    November 2003 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Universidad Autonoma de Queretaro
    Collaborators
    Procter and Gamble

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Anemia continues to be a major public health problem in many regions of the world and it is still not clear which strategy is more effective in children population in terms of adherence and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid fortified water.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia
    Keywords
    Anemia, Iron, Children, Micronutrients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    680 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anemic children
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron
    Intervention Description
    Daily 20mg of ferrous sulfate in liquid solution during 4 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multiple micronutrients supplement
    Intervention Description
    Daily supplement with 10mg of iron plus several micronutrients following a formula designed to treat anemia in indigenous population in Mexico. During 4 months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    micronutrient fortified porridge powder
    Intervention Description
    Daily powdered complementary food designed for a national program in Mexico with 10mg of iron plus several micronutrients during 4 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron and ascorbic acid fortified water
    Intervention Description
    A drink water product fortified with 6.7 mg ofiron, zinc and ascorbic acid. This product was asked to be used for drinking and for cooking for the child during 4 months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron plus folic acid supplement
    Intervention Description
    Daily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    42 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hemoglobin less than 11.7g/dL and above 7.0g/dL Exclusion Criteria: Breastfeeding Chronic gastroenteritis Any other severe illness

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20863398
    Citation
    Rosado JL, Gonzalez KE, Caamano Mdel C, Garcia OP, Preciado R, Odio M. Efficacy of different strategies to treat anemia in children: a randomized clinical trial. Nutr J. 2010 Sep 23;9:40. doi: 10.1186/1475-2891-9-40.
    Results Reference
    derived

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    Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children

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