Iron Deficiency Anemia, Infectious Diseases, Undernutrition
Conditions
Keywords
Clinical trial, controlled, Micronutrients, Dietary Supplementation, Infants
Brief 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.
Interventions
DIETARY_SUPPLEMENTSprinkles
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_SUPPLEMENTFerripel-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
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Months to 2 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) | 12, 18, 24 months |
Countries
Israel
Outcome results
None listed