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Completed

NCT Number: NCT04623918

Iron-Biofortified Rice Intervention 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of the Philippines

Los Baños, Laguna, 4031, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron-biofortified rice

Other

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

Control rice

Other

Control rice (C4), identical in appearance

Primary outcomes

  1. Change in serum ferritin

    Time frame: 9 months

    Serum ferritin (SF)

  2. Change in sTfR

    Time frame: 9 months

    Soluble transferrin receptor (sTfR)

  3. Change in TBI

    Time frame: 9 months

    Total body iron (TBI)

Secondary outcomes

  1. Change in hemoglobin among women who were anemic at baseline

    Time frame: 9 months

    Changes in hemoglobin (Hb) in women who were anemic at baseline

  2. Changes in SF among women who were non-anemic at baseline

    Time frame: 9 months

    Changes in SF among women who were non-anemic at baseline

  3. Changes in sTfR among women who were non-anemic at baseline

    Time frame: 9 months

    Changes in sTfR among women who were non-anemic at baseline

  4. Changes in TBI among women who were non-anemic at baseline

    Time frame: 9 months

    Changes in TBI among women who were non-anemic at baseline

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • Penn State University
  • University of the Philippines

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Nov 10, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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