Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Soroka University Medical Center771 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

771

Conditions

Iron Deficiency Anemia Infectious Diseases Undernutrition

Interventions

SprinklesDIETARY_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.

Ferripel-3, Vitamins A&D dropsDIETARY_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

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ministry of Health

Beersheba, Israel

Outcomes

Primary Outcomes

Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)

Time frame: 12, 18 and 24 months

Micronutrient status (Iron, Zinc and B12 and Folic acid level)

Time frame: 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)

Time frame: 12, 18, 24 months

Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations

Time frame: 24 months

Secondary Outcomes

Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)

Time frame: 12, 18, 24 months

Growth parameters (WAZ, HAZ, WHZ)

Time frame: 12, 18, 24 months

Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.

Time frame: 12 months

Data from ClinicalTrials.gov

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