NCT00479102

Brief Summary

Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group. Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
Last Updated

May 25, 2007

Status Verified

May 1, 2007

First QC Date

May 24, 2007

Last Update Submit

May 24, 2007

Conditions

Iron DeficiencyAnemia

Keywords

Iron supplementationBabiesPrevention

Interventions

Ferripel-3 - iron polysaccharide complex for preventionDRUG

Eligibility Criteria

Age8 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy babies without iron deficiency

You may not qualify if:

  • Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services Child Health Center

Rahat, Israel

Location

MeSH Terms

Conditions

Iron DeficienciesAnemia

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Hanna Shalev, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Shalev, MD

CONTACT

972-52-8504058hannash@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Study Start

May 1, 2007

Last Updated

May 25, 2007

Record last verified: 2007-05

Locations

IL(1)