Iron-Biofortified Rice Intervention in the Philippines
Primary Purpose
Iron-deficiency, Anemia
Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Iron-biofortified rice
Control rice
Sponsored by
About this trial
This is an interventional prevention trial for Iron-deficiency focused on measuring Anemia, Iron, Biofortification, Philippines, Iron deficiency, Women of reproductive age
Eligibility Criteria
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
Sites / Locations
- University of the Philippines
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Iron-biofortified rice
Control rice
Arm Description
Iron-biofortified rice (IR68144-2B-2-2-3)
Control rice (C4)
Outcomes
Primary Outcome Measures
Change in serum ferritin
Serum ferritin (SF)
Change in sTfR
Soluble transferrin receptor (sTfR)
Change in TBI
Total body iron (TBI)
Secondary Outcome Measures
Change in hemoglobin among women who were anemic at baseline
Changes in hemoglobin (Hb) in women who were anemic at baseline
Changes in SF among women who were non-anemic at baseline
Changes in SF among women who were non-anemic at baseline
Changes in sTfR among women who were non-anemic at baseline
Changes in sTfR among women who were non-anemic at baseline
Changes in TBI among women who were non-anemic at baseline
Changes in TBI among women who were non-anemic at baseline
Full Information
NCT ID
NCT04623918
First Posted
November 4, 2020
Last Updated
November 10, 2020
Sponsor
Cornell University
Collaborators
Penn State University, University of the Philippines
1. Study Identification
Unique Protocol Identification Number
NCT04623918
Brief Title
Iron-Biofortified Rice Intervention in the Philippines
Official Title
Randomized Trial of Iron-Biofortified Rice in Women in the Philippines
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2002 (Actual)
Primary Completion Date
December 31, 2003 (Actual)
Study Completion Date
December 31, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
Penn State University, University of the Philippines
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Anemia
Keywords
Anemia, Iron, Biofortification, Philippines, Iron deficiency, Women of reproductive age
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron-biofortified rice
Arm Type
Experimental
Arm Description
Iron-biofortified rice (IR68144-2B-2-2-3)
Arm Title
Control rice
Arm Type
Active Comparator
Arm Description
Control rice (C4)
Intervention Type
Other
Intervention Name(s)
Iron-biofortified rice
Intervention Description
Iron-biofortified rice (IR68144-2B-2-2-3)
Intervention Type
Other
Intervention Name(s)
Control rice
Intervention Description
Control rice (C4), identical in appearance
Primary Outcome Measure Information:
Title
Change in serum ferritin
Description
Serum ferritin (SF)
Time Frame
9 months
Title
Change in sTfR
Description
Soluble transferrin receptor (sTfR)
Time Frame
9 months
Title
Change in TBI
Description
Total body iron (TBI)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change in hemoglobin among women who were anemic at baseline
Description
Changes in hemoglobin (Hb) in women who were anemic at baseline
Time Frame
9 months
Title
Changes in SF among women who were non-anemic at baseline
Description
Changes in SF among women who were non-anemic at baseline
Time Frame
9 months
Title
Changes in sTfR among women who were non-anemic at baseline
Description
Changes in sTfR among women who were non-anemic at baseline
Time Frame
9 months
Title
Changes in TBI among women who were non-anemic at baseline
Description
Changes in TBI among women who were non-anemic at baseline
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jere Haas
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Philippines
City
Los Baños
State/Province
Laguna
ZIP/Postal Code
4031
Country
Philippines
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16317127
Citation
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.
Results Reference
background
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Iron-Biofortified Rice Intervention in the Philippines
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