Iron Deficiency Anemia Clinical Trial
Official title:
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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