Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Periconceptional Iron Supplementation in Rural Bangladesh

This study has been completed.
Information provided by:
The Hospital for Sick Children Identifier:
First received: August 4, 2009
Last updated: April 14, 2010
Last verified: August 2009
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.

Condition Intervention Phase
Dietary Supplement: Ferrous fumarate (iron)
Dietary Supplement: folic acid
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.

Resource links provided by NLM:

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: February 2007-February 2008 ]

Secondary Outcome Measures:
  • Plasma ferritin [ Time Frame: February 2007-February 2008 ]

Enrollment: 273
Study Start Date: February 2007
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)
Dietary Supplement: folic acid
400 mcg folic acid
Other Name: 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 Name: Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)

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).

Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00953134

Dhaka, Dhaka Division, Bangladesh, 1212
Sponsors and Collaborators
The Hospital for Sick Children
Study Director: Amina Khambalia, MSc The Hospital for Sick Children
  More Information

Additional Information:
brac  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Stanley Zlotkin, Hospital for Sick Children Identifier: NCT00953134     History of Changes
Other Study ID Numbers: Periconceptional_Fe
Study First Received: August 4, 2009
Last Updated: April 14, 2010

Keywords provided by The Hospital for Sick Children:
folic acid

Additional relevant MeSH terms:
Trace Elements
Ferrous fumarate
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Vitamins processed this record on May 25, 2017