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Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276198
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 16, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Infectious Diseases Undernutrition Dietary Supplement: Sprinkles Dietary Supplement: Ferripel-3, Vitamins A&D drops Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 771 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : July 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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 Name: oral drops

No Intervention: 3
No intervention except for checking outcomes at approprite times.

Primary Outcome Measures :
  1. Haemotological parameters (haemoglobin, transferrin saturation, and ferritin) [ Time Frame: 12, 18 and 24 months ]
  2. Micronutrient status (Iron, Zinc and B12 and Folic acid level) [ Time Frame: 12, 18 months ]
  3. 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 ]
  4. Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations [ Time Frame: 24 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276198

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Ministry of Health
Beer-Sheva, Israel, 10050
Sponsors and Collaborators
Soroka University Medical Center
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Principal Investigator: Drora Fraser, PhD Ben-Gurion University of the Negev
Additional Information:
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Responsible Party: Naomi Amichai, Soroka University Medical Center Identifier: NCT00276198    
Other Study ID Numbers: sor395705ctil
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: March 2008
Keywords provided by Soroka University Medical Center:
Clinical trial, controlled
Dietary Supplementation
Additional relevant MeSH terms:
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Communicable Diseases
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Vitamin D
Vitamin A
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents