Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.

Soroka University Medical Center

Status and phase: Unknown; Phase 4

Conditions: Anemia; Iron Deficiency

Treatments: Drug: Ferrous gluconate and iron polysaccharide complex

Study type: Interventional

Funder types: Other

Identifiers

NCT00248716

sor458607ctil

Details and patient eligibility

About

Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:

1. Iron deficiency with no anemia
2. anemia
3. no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of life. Groups 1 and 2 will randomly receive one of two preparations currently in use for treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 - iron polysaccharide complex). Followup blood count will be taken 3 month after recruitment. The study aims to compare the effectiveness of the Iron preparations regarding compliance and efficacy.

The hypothesis is that a significant difference will be detected between the two preparations.

Enrollment: 200 estimated patients

Sex: All

Ages: 9 to 18 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy toddlers age 9-18 months

Exclusion criteria

• Toddlers with: chronic diseases, prematurity, inherited hematological disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)