NCT00198848

Brief Summary

This study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal, India.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 20, 2018

Status Verified

January 1, 2006

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

April 18, 2018

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemiaAdolescent girlsIndia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of anemia after 1 year of intervention

Secondary Outcomes (5)

  • Knowledge of anemia

  • Practices regarding treatment and prevention of anemia

  • Knowledge of iron supplements

  • Practices regarding iron supplements

  • Dietary iron intake

Interventions

Iron-folic acid supplementDRUG

Eligibility Criteria

Age12 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Girl 12-19 years of age
  • Resides in study area

You may not qualify if:

  • Does not reside in study area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child In Need Institute

Kolkata, West Bengal, India

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Michele L Dreyfuss, PhD, MPH

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 20, 2018

Record last verified: 2006-01

Locations

IN(1)