Prevention of Iron Deficiency in 2nd Year of Life

NCT ID: NCT00479102

Last Updated: 2007-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency Anemia

Keywords

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Iron supplementation Babies Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Ferripel-3 - iron polysaccharide complex for prevention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy babies without iron deficiency

Exclusion Criteria

* Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease
Minimum Eligible Age

8 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Hanna Shalev, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services

Locations

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Clalit Health Services Child Health Center

Rahat, , Israel

Site Status

Countries

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Israel

Central Contacts

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Hanna Shalev, MD

Role: CONTACT

Phone: 972-52-8504058

Email: [email protected]

Facility Contacts

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Hanna Shalev, MD

Role: primary

Other Identifiers

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sor448707ctil

Identifier Type: -

Identifier Source: org_study_id