Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
NCT ID: NCT00276198
Last Updated: 2008-04-16
Study Results
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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COMPLETED
PHASE3
771 participants
INTERVENTIONAL
2005-07-31
2007-12-31
Brief Summary
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Detailed Description
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We will compare in Bedouin and Jewish children separately the efficacy of daily use of Sprinkles(home Micronutrient fortification) from age 6 to 12 months in infants recruited in Maternal and Child Health clinics.
The comparison will be children recruited in clinics of comparable socioeconomic status, where current Ministry of Health recommendations (drops of iron and vitamins A plus D) are the treatment regimen.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Supplementation with daily sprinkle package
Sprinkles
Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.
2
Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations.
Ferripel-3, Vitamins A&D drops
Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months
3
No intervention except for checking outcomes at approprite times.
No interventions assigned to this group
Interventions
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Sprinkles
Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.
Ferripel-3, Vitamins A&D drops
Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infant whose parents give their written informed consent
* Infants whose parents intend to reside within the area for at least 12 months
* Infants receiving any additional food besides breast feeding
Exclusion Criteria
* Known or suspected anemia (Hb \<11 gr/dl)
* Known or suspected immunological disorders
* Known or suspected malabsorption disorders
* Enrolled or scheduled to be enrolled in another clinical trial
5 Months
2 Years
ALL
Yes
Sponsors
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Soroka University Medical Center
OTHER
Responsible Party
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Soroka University Medical Center
Principal Investigators
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Drora Fraser, PhD
Role: PRINCIPAL_INVESTIGATOR
Ben-Gurion University of the Negev
Locations
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Ministry of Health
Beersheba, , Israel
Countries
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References
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Fraser D, Shahar D, Shai I, Vardi H, Bilenko N. Negev nutritional studies: nutritional deficiencies in young and elderly populations. Public Health Rev. 2000;28(1-4):31-46.
Related Links
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The site that describes the intervention treatment
Other Identifiers
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sor395705ctil
Identifier Type: -
Identifier Source: org_study_id