Iron-Biofortified Rice Intervention in the Philippines

Study Overview
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Brief Summary
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The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.

Detailed Description
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Iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. In this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. Women living in convents in the greater Manila area were recruited for this study. These women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively. The investigators hypothesized that daily consumption of iron-biofortified rice (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. In order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of Manila, Philippines for 9 months. The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. The long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.

Official Title
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Randomized Trial of Iron-Biofortified Rice in Women in the Philippines

Conditions
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Iron-deficiency, Anemia

Intervention / Treatment
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* Other: Iron-biofortified rice
* Other: Control rice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women (18-45 years old) living in convents in the greater Manila area Hb ≥10.5 g/dL Exclusion Criteria: Current or history of gastrointestinal or hematological disorders Taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption Hb <10.5 g/dL Women expressed uncertainty in their ability to participate for the full (9 month) trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron-biofortified rice<br>Iron-biofortified rice (IR68144-2B-2-2-3) | Other: Iron-biofortified rice<br>* Iron-biofortified rice (IR68144-2B-2-2-3)<br>|
| Active Comparator: Control rice<br>Control rice (C4) | Other: Control rice<br>* Control rice (C4), identical in appearance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum ferritin | Serum ferritin (SF) | 9 months | 
| Change in sTfR | Soluble transferrin receptor (sTfR) | 9 months | 
| Change in TBI | Total body iron (TBI) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin among women who were anemic at baseline | Changes in hemoglobin (Hb) in women who were anemic at baseline | 9 months | 
| Changes in SF among women who were non-anemic at baseline | Changes in SF among women who were non-anemic at baseline | 9 months | 
| Changes in sTfR among women who were non-anemic at baseline | Changes in sTfR among women who were non-anemic at baseline | 9 months | 
| Changes in TBI among women who were non-anemic at baseline | Changes in TBI among women who were non-anemic at baseline | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Iron, Biofortification, Philippines, Iron deficiency, Women of reproductive age