Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
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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. |
- 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 ]
- 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 |
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 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 Communicable Diseases Infection Deficiency Diseases Anemia, Iron-Deficiency Malnutrition Hematologic Diseases Nutrition Disorders Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Micronutrients Vitamin A Vitamin D |
Trace Elements Vitamins Retinol palmitate Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013