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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Supplementation with daily sprinkle package |
|
| 2 | Active Comparator | Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations. |
|
| 3 | No Intervention | No intervention except for checking outcomes at approprite times. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sprinkles | Dietary Supplement | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemotological parameters (haemoglobin, transferrin saturation, and ferritin) | 12, 18 and 24 months | |
| Micronutrient status (Iron, Zinc and B12 and Folic acid level) | 12, 18 months | |
| Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM) | 12, 18, 24 months | |
| Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) | 12, 18, 24 months | |
| Growth parameters (WAZ, HAZ, WHZ) | 12, 18, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drora Fraser, PhD | Ben-Gurion University of the Negev | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ministry of Health | Beersheba | 10050 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11411276 | Background | 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. |
| Label | URL |
|---|---|
| The site that describes the intervention treatment | View source |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D003141 | Communicable Diseases |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Ferripel-3, Vitamins A&D drops | Dietary Supplement | 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 |
|
|
| Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events. | 12 months |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |