University of the Philippines
Los Baños, Laguna, 4031, Philippines
NCT Number: NCT04623918
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Los Baños, Laguna, 4031, Philippines
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Iron-biofortified rice (IR68144-2B-2-2-3)
Control rice (C4), identical in appearance
Time frame: 9 months
Serum ferritin (SF)
Time frame: 9 months
Soluble transferrin receptor (sTfR)
Time frame: 9 months
Total body iron (TBI)
Time frame: 9 months
Changes in hemoglobin (Hb) in women who were anemic at baseline
Time frame: 9 months
Changes in SF among women who were non-anemic at baseline
Time frame: 9 months
Changes in sTfR among women who were non-anemic at baseline
Time frame: 9 months
Changes in TBI among women who were non-anemic at baseline
Cornell University
Other
Randomized Trial of Iron-Biofortified Rice in Women in the Philippines
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