Periconceptional Iron Supplementation in Rural Bangladesh

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00953134

Enrollment

273

Registered

2009-08-06

Start date

2007-02-28

Completion date

2008-03-31

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

periconceptional, iron, folic acid, supplementation

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).

Interventions

DIETARY_SUPPLEMENTfolic acid

400 mcg folic acid

DIETARY_SUPPLEMENTFerrous fumarate (iron)

60 mg of ferrous fumarate

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin	February 2007-February 2008

Secondary

Measure	Time frame
Plasma ferritin	February 2007-February 2008

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026