Anemia, Iron-deficiency
Conditions
Keywords
Anemia, Iron, Biofortification, Philippines, Iron deficiency, Women of reproductive age
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.
Interventions
OTHERIron-biofortified rice
Iron-biofortified rice (IR68144-2B-2-2-3)
OTHERControl rice
Control rice (C4), identical in appearance
Sponsors
Penn State University
University of the Philippines
Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum ferritin | 9 months | Serum ferritin (SF) |
| Change in sTfR | 9 months | Soluble transferrin receptor (sTfR) |
| Change in TBI | 9 months | Total body iron (TBI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 TBI among women who were non-anemic at baseline | 9 months | Changes in TBI among women who were non-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 sTfR among women who were non-anemic at baseline | 9 months | Changes in sTfR among women who were non-anemic at baseline |
Countries
Philippines
Outcome results
None listed