NCT00136266

Brief Summary

Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

February 3, 2016

Status Verified

September 1, 2007

Enrollment Period

9 months

First QC Date

August 25, 2005

Last Update Submit

February 2, 2016

Conditions

AnemiaIron Deficiency

Keywords

AdherenceSupplementsIronIron deficiencyAnemiaVitaminsMinerals

Outcome Measures

Primary Outcomes (1)

  • full adherence, use of iron supplements 6-7 days/week for 3 months

Secondary Outcomes (2)

  • iron deficiency at 9 months of age

  • anemia at 9 months of age

Interventions

Ferrous sulphate drops with vitamins A, D, and CDRUG
Ferrous fumarate sprinkles with vitamins and mineralsDRUG

Eligibility Criteria

Age5 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants
  • Age 5-7 months
  • Presenting for 6 months well-child care
  • Caregiver speaks English or Spanish

You may not qualify if:

  • Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)
  • Inability to speak English or Spanish
  • Use of vitamin or iron supplements in the previous three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Whittier Street Health Center

Boston, Massachusetts, 02108, United States

Location

Boston Medical Center Pediatric Primary Care Clinic

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Geltman PL, Hironaka LK, Mehta SD, Padilla P, Rodrigues P, Meyers AF, Bauchner H. Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops. J Pediatr. 2009 May;154(5):738-43. doi: 10.1016/j.jpeds.2008.11.003. Epub 2008 Dec 25.

    PMID: 19111318RESULT

MeSH Terms

Conditions

AnemiaIron Deficiencies

Interventions

Fumigant 93VitaminsMinerals

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesInorganic Chemicals

Study Officials

  • Paul L. Geltman, MD, MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

February 3, 2016

Record last verified: 2007-09

Locations

US(2)