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| Name | Class |
|---|---|
| Penn State University | OTHER |
| University of the Philippines | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron-biofortified rice | Experimental | Iron-biofortified rice (IR68144-2B-2-2-3) |
|
| Control rice | Active Comparator | Control rice (C4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron-biofortified rice | Other | Iron-biofortified rice (IR68144-2B-2-2-3) |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jere Haas | Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Philippines | Los Baños | Laguna | 4031 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16317127 | Background | Haas JD, Beard JL, Murray-Kolb LE, del Mundo AM, Felix A, Gregorio GB. Iron-biofortified rice improves the iron stores of nonanemic Filipino women. J Nutr. 2005 Dec;135(12):2823-30. doi: 10.1093/jn/135.12.2823. |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
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Masking description: The study was a double-blind, randomized controlled trial of; (1) iron-biofortified rice (IR68144-2B-2-2-3), compared to (2) a commercially available variety of rice (C4), with the intervention randomized at the individual level. Administrators, participants, research staff (i.e. responsible for daily data collection and preparation of rice for all meals, assessment of outcomes), and laboratory staff were blinded to the intervention group.
| Control rice |
| Other |
Control rice (C4), identical in appearance |
|
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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |