NCT04623918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2003

Completed
16.9 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

November 4, 2020

Last Update Submit

November 10, 2020

Conditions

Iron-deficiencyAnemia

Keywords

AnemiaIronBiofortificationPhilippinesIron deficiencyWomen of reproductive age

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Change in hemoglobin among women who were anemic at baseline

    9 months

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

    9 months

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

    9 months

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

    9 months

Study Arms (2)

Iron-biofortified rice

EXPERIMENTAL

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

Other: Iron-biofortified rice

Control rice

ACTIVE COMPARATOR

Control rice (C4)

Other: Control rice

Interventions

Iron-biofortified riceOTHER

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

Iron-biofortified rice
Control riceOTHER

Control rice (C4), identical in appearance

Control rice

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women (18-45 years old) living in convents in the greater Manila area
  • Hb ≥10.5 g/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Philippines

Los Baños, Laguna, 4031, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 16317127BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemiaIron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jere Haas

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

June 1, 2002

Primary Completion

December 31, 2003

Study Completion

December 31, 2003

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)