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NCT00479102 Clinical Trial

Prevention of Iron Deficiency in 2nd Year of Life

Anemia Clinical Trial

Official title:
Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00479102
Other study ID # sor448707ctil
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received May 24, 2007
Last updated May 24, 2007
Start date May 2007

Study information
Verified date May 2007
Source Soroka University Medical Center
Contact Hanna Shalev, MD
Phone 972-52-8504058
Email hannash@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Months to 18 Months
Eligibility Inclusion Criteria:

- Healthy babies without iron deficiency

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Ferripel-3 - iron polysaccharide complex for prevention

Locations
Country Name City State
Israel Clalit Health Services Child Health Center Rahat

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

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