Iron Supplementation Among Adolescent Girls in India

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00198848
• Collaborator: Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 2,800
• Location: 1
• Duration (Months): 21.9
• Patients Per Site Per Month: 127.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Drug: Iron-folic acid supplement	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2800 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Iron Supplementation Among Adolescent Girls in India
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Prevalence of anemia after 1 year of intervention []

Secondary Outcome Measures

1. Knowledge of anemia []

2. Practices regarding treatment and prevention of anemia []

3. Knowledge of iron supplements []

4. Practices regarding iron supplements []

5. Dietary iron intake []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 19 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Girl 12-19 years of age

• Resides in study area

Exclusion Criteria:

• Does not reside in study area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Child In Need Institute	Kolkata	West Bengal	India

Sponsors and Collaborators

• Johns Hopkins Bloomberg School of Public Health
• Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Michele L Dreyfuss, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00198848
• Other Study ID Numbers: H.32.04.11.22.A2; S3433-23/23 (ASPH)
• First Posted: Sep 20, 2005
• Last Update Posted: Apr 20, 2018
• Last Verified: Jan 1, 2006

• Keywords provided by , ,: Iron deficiency anemia; Adolescent girls; India
• Additional relevant MeSH terms: Anemia, Iron-Deficiency; Folic Acid

Study Results

No Results Posted as of Apr 20, 2018