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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 771
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Sprinkles
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.

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

Ages Eligible for Study:   5 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276198

Locations
Israel
Ministry of Health
Beer-Sheva, Israel, 10050
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Drora Fraser, PhD Ben-Gurion University of the Negev
  More Information

Additional Information:
Publications:
Responsible Party: Naomi Amichai, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00276198     History of Changes
Other Study ID Numbers: sor395705ctil
Study First Received: January 11, 2006
Last Updated: April 15, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Clinical trial, controlled
Micronutrients
Dietary Supplementation
Infants

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Communicable Diseases
Infection
Nutrition Disorders
Malnutrition
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin A
Micronutrients
Trace Elements
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014