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Iron-Biofortified Rice Intervention in the Philippines

NCT ID: NCT04623918

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-01

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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Iron-deficiency Anemia

Keywords

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Anemia Iron Biofortification Philippines Iron deficiency Women of reproductive age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Iron-biofortified rice

Iron-biofortified rice (IR68144-2B-2-2-3)

Group Type EXPERIMENTAL

Iron-biofortified rice

Intervention Type OTHER

Iron-biofortified rice (IR68144-2B-2-2-3)

Control rice

Control rice (C4)

Group Type ACTIVE_COMPARATOR

Control rice

Intervention Type OTHER

Control rice (C4), identical in appearance

Interventions

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Iron-biofortified rice

Iron-biofortified rice (IR68144-2B-2-2-3)

Intervention Type OTHER

Control rice

Control rice (C4), identical in appearance

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Penn State University

OTHER

Sponsor Role collaborator

University of the Philippines

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jere Haas

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

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University of the Philippines

Los Baños, Laguna, Philippines

Site Status

Countries

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Philippines

References

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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.

Reference Type BACKGROUND
PMID: 16317127 (View on PubMed)

Other Identifiers

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Haas2005

Identifier Type: -

Identifier Source: org_study_id