Periconceptional Iron Supplementation in Rural Bangladesh

Early Phase 1

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Ferrous fumarate (iron); Dietary Supplement: folic acid

• Registration Number: NCT00953134
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 273

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	folic acid	IFA - Iron and Folic Acid (60 mg of ferrous fumarate and 400 mcg folic acid)
2	folic acid	FA - Folic Acid (400 mcg folic acid)
1	Ferrous fumarate (iron)	IFA - Iron and Folic Acid (60 mg of ferrous fumarate and 400 mcg folic acid)

Primary Outcome Measures

Name	Time	Method
Hemoglobin	February 2007-February 2008

Secondary Outcome Measures

Name	Time	Method
Plasma ferritin	February 2007-February 2008

Trial Locations

Locations (1)

Brac; 🇧🇩 Dhaka, Dhaka Division, Bangladesh