Periconceptional Iron Supplementation in Rural Bangladesh

April 14, 2021 updated by: Stanley Zlotkin, The Hospital for Sick Children

Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.

The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In 2007, the National Strategy for Anemia Prevention and Control in Bangladesh included adolescents and newly married women as target groups for future iron and folic acid (IFA) supplementation programs. This double-blinded RCT examined the effect of daily periconceptional IFA vs. folic acid (FA) on anemia and iron indictors before and during pregnancy among married, nulliparous women in rural Bangladesh. Biochemical indices were collected at baseline and either at 15 weeks gestation or after 9 months among non-pregnant women (NPW).

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Dhaka Division
      • Dhaka, Dhaka Division, Bangladesh, 1212
        • Brac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women were eligible if they were:

  • Married
  • Nulliparous
  • < 40 years old
  • Living in the same household as their husband

Exclusion Criteria:

Women were excluded if they were:

  • Pregnant at enrollment
  • Planning to move out of the region
  • Using iron supplements within the previous 3 months
  • Using an implant form of birth control, or had surgery to prevent pregnancy
  • Women with a Hb concentration of < 70 g/L, defined as severely anemic according to WHO definition (5), were excluded from the study and appropriately treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
IFA - Iron and Folic Acid (60 mg of ferrous fumarate and 400 mcg folic acid)
Dietary supplement: Ferrous fumarate (iron)
60 mg of ferrous fumarate
Other Names:
  • Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)
Dietary supplement: folic acid
400 mcg folic acid
Other Names:
  • Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)
Active Comparator: 2
FA - Folic Acid (400 mcg folic acid)
Dietary supplement: folic acid
400 mcg folic acid
Other Names:
  • Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin
Time Frame: February 2007-February 2008
February 2007-February 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma ferritin
Time Frame: February 2007-February 2008
February 2007-February 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Study Director: Amina Khambalia, MSc, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Periconceptional_Fe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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