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Periconceptional Iron Supplementation in Rural Bangladesh

T

The Hospital for Sick Children

Status and phase

Completed
Early Phase 1

Conditions

Anemia

Treatments

Dietary Supplement: folic acid
Dietary Supplement: Ferrous fumarate (iron)

Study type

Interventional

Funder types

Other

Identifiers

NCT00953134
Periconceptional_Fe

Details and patient eligibility

About

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.

Full 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).

Enrollment

273 patients

Sex

Female

Ages

Under 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

273 participants in 2 patient groups

1
Experimental group
Description:
IFA - Iron and Folic Acid (60 mg of ferrous fumarate and 400 mcg folic acid)
Treatment:
Dietary Supplement: Ferrous fumarate (iron)
Dietary Supplement: folic acid
2
Active Comparator group
Description:
FA - Folic Acid (400 mcg folic acid)
Treatment:
Dietary Supplement: folic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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