The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children

Federal University of Minas Gerais

Status: Completed

Conditions: Iron Deficiency Anemia; Anemia

Treatments: Dietary Supplement: iron drops; Dietary Supplement: iron fortified rice

Study type: Interventional

Funder types: Other

Identifiers

NCT00839761

FDAAA

Details and patient eligibility

About

Background: How best to improve iron status among infants in low-income settings is of continued concern in many countries, including Brazil

Objective:

Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with 23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on the correct dosage of iron drops and to feed their children (including whether and how much rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and at 5 mo.

Enrollment: 175 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• anemia

Exclusion criteria

• non anemic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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175 participants in 2 patient groups, including a placebo group

iron fortified rice group

Experimental group

Treatment:

Dietary Supplement: iron fortified rice

iron drop group

Placebo Comparator group

Treatment:

Dietary Supplement: iron drops