Clinical trial NCT00276198: Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Infectious Diseases
Undernutrition
Keywords: Clinical trial, controlled
Micronutrients
Dietary Supplementation
Infants
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 771
Sex: ALL
Minimum age (years): 5
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)
timeFrame: 12, 18 and 24 months
measure: Micronutrient status (Iron, Zinc and B12 and Folic acid level)
timeFrame: 12, 18 months
measure: Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM)
timeFrame: 12, 18, 24 months
measure: Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations
timeFrame: 24 months
Secondary outcomes:
measure: Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)
timeFrame: 12, 18, 24 months
measure: Growth parameters (WAZ, HAZ, WHZ)
timeFrame: 12, 18, 24 months
measure: Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.
timeFrame: 12 months
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Ministry of Health
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Drora Fraser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fraser D, Shahar D, Shai I, Vardi H, Bilenko N. Negev nutritional studies: nutritional deficiencies in young and elderly populations. Public Health Rev. 2000;28(1-4):31-46.