Periconceptional Iron Supplementation in Rural Bangladesh

Study Overview
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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).

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

Conditions
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Anemia

Intervention / Treatment
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* Dietary Supplement: Ferrous fumarate (iron)
* Dietary Supplement: folic acid


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IFA - Iron and Folic Acid (60 mg of ferrous fumarate and 400 mcg folic acid) | Dietary Supplement: Ferrous fumarate (iron)<br>* 60 mg of ferrous fumarate<br>* Other names: Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd);Dietary Supplement: folic acid<br>* 400 mcg folic acid<br>* Other names: Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd);|
| Active Comparator: 2<br>FA - Folic Acid (400 mcg folic acid) | Dietary Supplement: folic acid<br>* 400 mcg folic acid<br>* Other names: Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin |  | February 2007-February 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma ferritin |  | February 2007-February 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periconceptional, iron, folic acid, supplementation