Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Iron Deficiency Anemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276198
• Other study ID #: sor395705ctil
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2006
• Last updated: April 15, 2008
• Start date: July 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 771
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Months to 2 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Communicable Diseases
• Infection
• Infectious Diseases
• Iron Deficiency Anemia
• Malnutrition
• Undernutrition

Intervention

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.
• 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

Locations

Country	Name	City	State
Israel	Ministry of Health	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)		12, 18 and 24 months	No
Primary	Micronutrient status (Iron, Zinc and B12 and Folic acid level)		12, 18 months	No
Primary	Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM)		12, 18, 24 months	No
Primary	Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations		24 months	No
Secondary	Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)		12, 18, 24 months	No
Secondary	Growth parameters (WAZ, HAZ, WHZ)		12, 18, 24 months	No
Secondary	Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.		12 months	Yes

External Links

•   Research profile of Ben-Gurion University staff members
•   The site that describes the intervention treatment