Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
|ClinicalTrials.gov Identifier: NCT00276198|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 16, 2008
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||771 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
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.
- Haemotological parameters (haemoglobin, transferrin saturation, and ferritin) [ Time Frame: 12, 18 and 24 months ]
- Micronutrient status (Iron, Zinc and B12 and Folic acid level) [ Time Frame: 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 ]
- Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations [ Time Frame: 24 months ]
- Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) [ Time Frame: 12, 18, 24 months ]
- Growth parameters (WAZ, HAZ, WHZ) [ Time Frame: 12, 18, 24 months ]
- Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276198
|Ministry of Health|
|Beer-Sheva, Israel, 10050|
|Principal Investigator:||Drora Fraser, PhD||Ben-Gurion University of the Negev|