Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00276198
First received: January 11, 2006
Last updated: April 15, 2008
Last verified: March 2008

January 11, 2006
April 15, 2008
July 2005
December 2007   (final data collection date for primary outcome measure)
  • Haemotological parameters (haemoglobin, transferrin saturation, and ferritin) [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Micronutrient status (Iron, Zinc and B12 and Folic acid level) [ Time Frame: 12, 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00276198 on ClinicalTrials.gov Archive Site
  • Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) [ Time Frame: 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Growth parameters (WAZ, HAZ, WHZ) [ Time Frame: 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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.
Not Provided
Not Provided
 
Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Iron Deficiency Anemia
  • Infectious Diseases
  • Undernutrition
  • 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.
    Other Name: Sprinkles
  • 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
  • Experimental: 1
    Supplementation with daily sprinkle package
    Intervention: Dietary Supplement: Sprinkles
  • Active Comparator: 2
    Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations.
    Intervention: Dietary Supplement: Ferripel-3, Vitamins A&D drops
  • No Intervention: 3
    No intervention except for checking outcomes at approprite times.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
771
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
5 Months to 2 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00276198
sor395705ctil
No
Naomi Amichai, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Drora Fraser, PhD Ben-Gurion University of the Negev
Soroka University Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP