Iron-Biofortified Rice Intervention in the Philippines

Cornell University

Status

Completed

Conditions

Anemia

Iron-deficiency

Treatments

Other: Control rice

Other: Iron-biofortified rice

Study type

Interventional

Funder types

Other

Identifiers

NCT04623918

Haas2005

Details and patient eligibility

About

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.

Full 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.

Enrollment

288 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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