Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Iron Deficiency Anemia, Infectious Diseases, Undernutrition

Intervention / Treatment
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* Dietary Supplement: Sprinkles
* Dietary Supplement: Ferripel-3, Vitamins A&D drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant aged 5-7 months 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 haemotological disorders 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

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Supplementation with daily sprinkle package | Dietary Supplement: Sprinkles<br>* 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.<br>|
| Active Comparator: 2<br>Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations. | Dietary Supplement: Ferripel-3, Vitamins A&D drops<br>* 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<br>* Other names: oral drops;|
| No Intervention: 3<br>No intervention except for checking outcomes at approprite times. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Clinical trial, controlled, Micronutrients, Dietary Supplementation