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

NCT ID: NCT00822380

Last Updated: 2009-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Anemic children

Group Type EXPERIMENTAL

Iron

Intervention Type DIETARY_SUPPLEMENT

Daily 20mg of ferrous sulfate in liquid solution during 4 months

Multiple micronutrients supplement

Intervention Type DIETARY_SUPPLEMENT

Daily supplement with 10mg of iron plus several micronutrients following a formula designed to treat anemia in indigenous population in Mexico. During 4 months.

micronutrient fortified porridge powder

Intervention Type DIETARY_SUPPLEMENT

Daily powdered complementary food designed for a national program in Mexico with 10mg of iron plus several micronutrients during 4 months

Iron and ascorbic acid fortified water

Intervention Type DIETARY_SUPPLEMENT

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.

Iron plus folic acid supplement

Intervention Type DIETARY_SUPPLEMENT

Daily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months

Interventions

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Iron

Daily 20mg of ferrous sulfate in liquid solution during 4 months

Intervention Type DIETARY_SUPPLEMENT

Multiple micronutrients supplement

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

micronutrient fortified porridge powder

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

Iron and ascorbic acid fortified water

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

Iron plus folic acid supplement

Daily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Breastfeeding
* Chronic gastroenteritis
* Any other severe illness
Minimum Eligible Age

6 Months

Maximum Eligible Age

42 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Universidad Autonoma de Queretaro

OTHER

Sponsor Role lead

Responsible Party

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Universidad Autonoma de Querétaro

References

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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.

Reference Type DERIVED
PMID: 20863398 (View on PubMed)

Other Identifiers

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FNN2002-07

Identifier Type: -

Identifier Source: org_study_id

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