Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

April 15, 2008 updated by: Soroka University Medical Center

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

771

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel, 10050
        • Ministry of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Supplementation with daily sprinkle package
Dietary supplement: Sprinkles
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.
Active Comparator: 2
Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations.
Dietary supplement: Ferripel-3, Vitamins A&D drops
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
Other Names:
  • oral drops
No Intervention: 3
No intervention except for checking outcomes at approprite times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)
Time Frame: 12, 18 and 24 months
12, 18 and 24 months
Micronutrient status (Iron, Zinc and B12 and Folic acid level)
Time Frame: 12, 18 months
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
12, 18, 24 months
Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)
Time Frame: 12, 18, 24 months
12, 18, 24 months
Growth parameters (WAZ, HAZ, WHZ)
Time Frame: 12, 18, 24 months
12, 18, 24 months
Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Principal Investigator: Drora Fraser, PhD, Ben-Gurion University of the Negev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

April 16, 2008

Last Update Submitted That Met QC Criteria

April 15, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor395705ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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