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OpenTrials
Completed

NCT Number: NCT00953134

Periconceptional Iron Supplementation 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.

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Key information

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Brac

Dhaka, Dhaka Division, 1212, Bangladesh

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous fumarate (iron)

Dietary Supplement

60 mg of ferrous fumarate

Other names: Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)

Folic Acid

Dietary Supplement

400 mcg folic acid

Other names: Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)

Primary outcomes

  1. Hemoglobin

    Time frame: February 2007-February 2008

Secondary outcomes

  1. Plasma ferritin

    Time frame: February 2007-February 2008

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 6, 2009
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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