Iron-Biofortified Rice Intervention in the Philippines
- Conditions
- Iron-deficiencyAnemia
- Interventions
- Other: Control riceOther: Iron-biofortified rice
- Registration Number
- NCT04623918
- Lead Sponsor
- Cornell University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 288
- Women (18-45 years old) living in convents in the greater Manila area
- Hb ≥10.5 g/dL
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control rice Control rice Control rice (C4) Iron-biofortified rice Iron-biofortified rice Iron-biofortified rice (IR68144-2B-2-2-3)
- Primary Outcome Measures
Name Time Method Change in sTfR 9 months Soluble transferrin receptor (sTfR)
Change in serum ferritin 9 months Serum ferritin (SF)
Change in TBI 9 months Total body iron (TBI)
- Secondary Outcome Measures
Name Time Method Changes in sTfR among women who were non-anemic at baseline 9 months Changes in sTfR among women who were non-anemic at baseline
Change in hemoglobin among women who were anemic at baseline 9 months Changes in hemoglobin (Hb) in women who were anemic at baseline
Changes in SF among women who were non-anemic at baseline 9 months Changes in SF among women who were non-anemic at baseline
Changes in TBI among women who were non-anemic at baseline 9 months Changes in TBI among women who were non-anemic at baseline
Trial Locations
- Locations (1)
University of the Philippines
🇵🇭Los Baños, Laguna, Philippines