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Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children
This study has been completed.
Sponsor:
Universidad Autonoma de Queretaro
Collaborator:
Procter and Gamble
Information provided by:
Universidad Autonoma de Queretaro
ClinicalTrials.gov Identifier:
NCT00822380
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Universidad Autonoma de Queretaro:
| 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 |
|---|---|
| Experimental: Anemic children |
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 (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Hemoglobin less than 11.7g/dL and above 7.0g/dL
Exclusion Criteria:
- Breastfeeding
- Chronic gastroenteritis
- Any other severe illness
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More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Jorge Luis Rosado Loria, Universidad Autonoma de Querétaro |
| ClinicalTrials.gov Identifier: | NCT00822380 History of Changes |
| Other Study ID Numbers: |
FNN2002-07 |
| Study First Received: | January 13, 2009 |
| Last Updated: | January 13, 2009 |
Keywords provided by Universidad Autonoma de Queretaro:
|
Anemia Iron Children Micronutrients |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases Iron Trace Elements Folic Acid Ascorbic Acid Micronutrients Vitamin B Complex |
Growth Substances Physiological Effects of Drugs Hematinics Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on July 19, 2017