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Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Information source: Soroka University Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Iron Deficiency Anemia; Infectious Diseases; Undernutrition

Intervention: Sprinkles (Dietary Supplement); Ferripel-3, Vitamins A&D drops (Dietary Supplement)

Phase: Phase 3

Status: Completed

Sponsored by: Soroka University Medical Center

Official(s) and/or principal investigator(s):
Drora Fraser, PhD, Principal Investigator, Affiliation: Ben-Gurion University of the Negev

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)

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

Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM)

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

Secondary outcome:

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

Growth parameters (WAZ, HAZ, WHZ)

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

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

Minimum age: 5 Months. Maximum age: 2 Years. Gender(s): Both.

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

Locations and Contacts

Ministry of Health, Beer-Sheva 10050, Israel
Additional Information

The site that describes the intervention treatment

Research profile of Ben-Gurion University staff members

Related publications:

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.

Starting date: July 2005
Last updated: April 15, 2008

Page last updated: August 20, 2015

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