NCT00276198

Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Controlled Clinical Trial to Assess the Effect of Multiple Micronutrient Supplementation (Iron, Vitamins A, C, D, Folic Acid and Zinc) on Nutritional and Health Indicators in Infants in Southern Israel.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 771 (estimated)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 5 Months – 2 Years
• Healthy volunteers: Accepted

Summary

The objective of the program is to examine the efficacy of 6 month home micronutrient supplementation in Bedouin and Jewish children on improvements in nutritional status including measures of iron, ferritin, zinc and folic acid, and measures of growth and health parameters i.e.reported and recorded morbidity.

Detailed description

The high level of anemia persists in Negev children despite the existence of a policy of the Ministry of Health that calls for Iron, Vitamin A and Vitamin D supplementation up to 12 months of age. In addition, other micronutrient deficiencies in this population have been described in several studies. These may be related to; low adherence with existing recommendations; need for additional micronutrients other than Iron, Vitamin A and Vitamin D; the need for a different delivery system more acceptable to mothers and infants. 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

• Iron Deficiency Anemia
• Infectious Diseases
• Undernutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-01-13
• Last updated: 2008-04-16

Locations

1 site across 1 country: Israel