Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Soroka University Medical Center

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia; Infectious Diseases; Undernutrition

Treatments: Dietary Supplement: Sprinkles; Dietary Supplement: Ferripel-3, Vitamins A&D drops

Study type: Interventional

Funder types: Other

Identifiers

NCT00276198

sor395705ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 771 estimated patients

Sex: All

Ages: 5 months to 2 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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771 participants in 3 patient groups

1

Experimental group

Description:

Supplementation with daily sprinkle package

Treatment:

Dietary Supplement: Sprinkles

2

Active Comparator group

Description:

Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations.

Treatment:

Dietary Supplement: Ferripel-3, Vitamins A&D drops

3

No Intervention group

Description:

No intervention except for checking outcomes at approprite times.