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

This study has been completed.

Sponsor:

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

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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:

MedlinePlus related topics: Anemia B Vitamins Dietary Supplements Folic Acid Iron Vitamin C

Drug Information available for: Ascorbic acid Folic acid Sodium ascorbate Vitamin B Complex Magnesium ascorbate

U.S. FDA Resources

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

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)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosado JL, González KE, Caamaño Mdel C, García 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.


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
Health Authority:	Mexico: Ministry of Health

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 September 23, 2016

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