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

Anemia Clinical Trial

Official title:

Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822380
• Other study ID #: FNN2002-07
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: January 13, 2009
• Start date: March 2003
• Est. completion date: November 2004

Study information

• Verified date: January 2009
• Source: Universidad Autonoma de Queretaro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: November 2004
• Est. primary completion date: November 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 42 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Breastfeeding

• Chronic gastroenteritis

• Any other severe illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• Iron
Daily 20mg of ferrous sulfate in liquid solution during 4 months
• 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.
• 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
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Queretaro	Procter and Gamble