ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00822380
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Universidad Autonoma de Queretaro

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial
Study Start Date : March 2003
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 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