Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Phase 3

Completed

• Conditions: Iron Deficiency Anemia; Infectious Diseases; Undernutrition
• Interventions: Dietary Supplement: Sprinkles; Dietary Supplement: Ferripel-3, Vitamins A&D drops

• Registration Number: NCT00276198
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 771

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sprinkles	Supplementation with daily sprinkle package
2	Ferripel-3, Vitamins A&D drops	Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ministry of Health; 🇮🇱 Beer-Sheva, Israel