NCT00276198

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
771

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 16, 2008

Status Verified

March 1, 2008

Enrollment Period

2.4 years

First QC Date

January 11, 2006

Last Update Submit

April 15, 2008

Conditions

Iron Deficiency AnemiaInfectious DiseasesUndernutrition

Keywords

Clinical trial, controlledMicronutrientsDietary SupplementationInfants

Outcome Measures

Primary Outcomes (4)

  • Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)

    12, 18 and 24 months

  • Micronutrient status (Iron, Zinc and B12 and Folic acid level)

    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)

    12, 18, 24 months

  • Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations

    24 months

Secondary Outcomes (3)

  • Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)

    12, 18, 24 months

  • Growth parameters (WAZ, HAZ, WHZ)

    12, 18, 24 months

  • Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.

    12 months

Study Arms (3)

1

EXPERIMENTAL

Supplementation with daily sprinkle package

Dietary Supplement: Sprinkles

2

ACTIVE COMPARATOR

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

3

NO INTERVENTION

No intervention except for checking outcomes at approprite times.

Interventions

SprinklesDIETARY_SUPPLEMENT

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.

1
Ferripel-3, Vitamins A&D dropsDIETARY_SUPPLEMENT

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

Also known as: oral drops
2

Eligibility Criteria

Age5 Months - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health

Beersheba, 10050, Israel

Location

Related 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.

    PMID: 11411276BACKGROUND

Related Links

MeSH Terms

Conditions

Anemia, Iron-DeficiencyCommunicable DiseasesMalnutrition

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition Disorders

Study Officials

  • Drora Fraser, PhD

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 13, 2006

Study Start

July 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 16, 2008

Record last verified: 2008-03

Locations

IL(1)