NCT00822380

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

8 months

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Keywords

AnemiaIronChildrenMicronutrients

Study Arms (1)

Anemic children

EXPERIMENTAL
Dietary Supplement: IronDietary Supplement: Multiple micronutrients supplementDietary Supplement: micronutrient fortified porridge powderDietary Supplement: Iron and ascorbic acid fortified waterDietary Supplement: Iron plus folic acid supplement

Interventions

IronDIETARY_SUPPLEMENT

Daily 20mg of ferrous sulfate in liquid solution during 4 months

Anemic children

Daily supplement with 10mg of iron plus several micronutrients following a formula designed to treat anemia in indigenous population in Mexico. During 4 months.

Anemic children

Daily powdered complementary food designed for a national program in Mexico with 10mg of iron plus several micronutrients during 4 months

Anemic children

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.

Anemic children

Daily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months

Anemic children

Eligibility Criteria

Age6 Months - 42 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Breastfeeding
  • Chronic gastroenteritis
  • Any other severe illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rosado JL, Gonzalez KE, Caamano Mdel C, Garcia 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.

MeSH Terms

Conditions

Anemia

Interventions

Iron

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

March 1, 2003

Primary Completion

November 1, 2003

Study Completion

November 1, 2004

Last Updated

January 14, 2009

Record last verified: 2009-01