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Periconceptional Iron Supplementation in Rural Bangladesh

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00953134
First received: August 4, 2009
Last updated: April 14, 2010
Last verified: August 2009
History of Changes
  Purpose

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
Anemia
 Dietary Supplement: Ferrous fumarate (iron)
Dietary Supplement: folic acid
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: February 2007-February 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma ferritin [ Time Frame: February 2007-February 2008 ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953134

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

Additional Information:
brac  This link exits the ClinicalTrials.gov site

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Stanley Zlotkin, Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00953134     History of Changes
Other Study ID Numbers: Periconceptional_Fe
Study First Received: August 4, 2009
Last Updated: April 14, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
periconceptional
iron
folic acid
supplementation

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Folic Acid
Vitamin B Complex
Hematinics
Ferrous fumarate
Iron
Micronutrients
 Trace Elements
Vitamins
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013