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| Sponsors and Collaborators: |
Universidad Autonoma de Queretaro Procter and Gamble |
|---|---|
| Information provided by: | Universidad Autonoma de Queretaro |
| ClinicalTrials.gov Identifier: | NCT00822380 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Anemia |
Dietary Supplement: Iron Dietary Supplement: Multiple micronutrients supplement Dietary Supplement: micronutrient fortified porridge powder Dietary Supplement: Iron and ascorbic acid fortified water Dietary Supplement: Iron plus folic acid supplement |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial |
| Enrollment: | 680 |
| Study Start Date: | March 2003 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Anemic children: Experimental |
Dietary Supplement: Iron
Daily 20mg of ferrous sulfate in liquid solution during 4 months
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.
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
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.
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
|
Eligibility| Ages Eligible for Study: | 6 Months to 42 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Universidad Autonoma de Querétaro ( Dr Jorge Luis Rosado Loria ) |
| Study ID Numbers: | FNN2002-07 |
| Study First Received: | January 13, 2009 |
| Last Updated: | January 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00822380 History of Changes |
| Health Authority: | Mexico: Ministry of Health |
|
Anemia Iron Children Micronutrients |
|
Antioxidants Vitamin B Complex Hematologic Diseases Hematinics Anemia Folate Trace Elements Folinic Acid Vitamin B9 |
Folic Acid Vitamin C Iron Supplement Vitamins Zinc Micronutrients Iron Ascorbic Acid |
|
Vitamin B Complex Antioxidants Molecular Mechanisms of Pharmacological Action Hematinics Hematologic Diseases Growth Substances Hematologic Agents Physiological Effects of Drugs Anemia |
Trace Elements Protective Agents Pharmacologic Actions Folic Acid Therapeutic Uses Vitamins Micronutrients Iron Ascorbic Acid |
