Periconceptional Iron Supplementation in Rural Bangladesh

NCT ID: NCT00953134

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-03-31

Brief Summary

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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

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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).

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

IFA - Iron and Folic Acid (60 mg of ferrous fumarate and 400 mcg folic acid)

Group Type EXPERIMENTAL

Ferrous fumarate (iron)

Intervention Type DIETARY_SUPPLEMENT

60 mg of ferrous fumarate

folic acid

Intervention Type DIETARY_SUPPLEMENT

400 mcg folic acid

2

FA - Folic Acid (400 mcg folic acid)

Group Type ACTIVE_COMPARATOR

folic acid

Intervention Type DIETARY_SUPPLEMENT

400 mcg folic acid

Interventions

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Ferrous fumarate (iron)

60 mg of ferrous fumarate

Intervention Type DIETARY_SUPPLEMENT

folic acid

400 mcg folic acid

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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

Eligibility Criteria

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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
Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Stanley Zlotkin

Chief, Global Child Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amina Khambalia, MSc

Role: STUDY_DIRECTOR

The Hospital for Sick Children

Locations

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Brac

Dhaka, Dhaka Division, Bangladesh

Site Status

Countries

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Bangladesh

References

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Khambalia AZ, O'Connor DL, Macarthur C, Dupuis A, Zlotkin SH. Periconceptional iron supplementation does not reduce anemia or improve iron status among pregnant women in rural Bangladesh. Am J Clin Nutr. 2009 Nov;90(5):1295-302. doi: 10.3945/ajcn.2009.28350. Epub 2009 Sep 30.

Reference Type DERIVED
PMID: 19793860 (View on PubMed)

Related Links

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Other Identifiers

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Periconceptional_Fe

Identifier Type: -

Identifier Source: org_study_id

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