Iron-Biofortified Rice Intervention in the Philippines

Randomized Trial of Iron-Biofortified Rice in Women in the Philippines

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Anemia
• Intervention / Treatment: Other: Iron-biofortified rice; Other: Control rice

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Laguna
    • Los Baños, Laguna, Philippines, 4031
      • University of the Philippines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron-biofortified rice; Iron-biofortified rice (IR68144-2B-2-2-3)	Other: Iron-biofortified rice; Iron-biofortified rice (IR68144-2B-2-2-3)
Active Comparator: Control rice; Control rice (C4)	Other: Control rice; Control rice (C4), identical in appearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: Penn State University; University of the Philippines
• Investigators: Principal Investigator: Jere Haas, Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2002
• Primary Completion (Actual): December 31, 2003
• Study Completion (Actual): December 31, 2003

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Anemia; Iron; Iron deficiency; Biofortification; Philippines; Women of reproductive age
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: Haas2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No