NCT01658488

Brief Summary

The purpose of this study is to see if rice enriched in iron will help women with iron-deficient anemia restore their blood counts more efficiently than the standard rice not enriched with iron.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

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

July 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

3.1 years

First QC Date

July 30, 2012

Last Update Submit

October 30, 2018

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemiarice

Outcome Measures

Primary Outcomes (1)

  • Change in reticulocyte count.

    Change in reticulocyte typically count in the iron-fortified rice group compared to the regular rice group. This is a test that measures how rapidly immature red blood cells called reticulocytes are made by the bone marrow and released into the blood.

    Baseline and 1 and 2 weeks following consumption of 2 servings

Secondary Outcomes (5)

  • Changes in serum iron

    Baseline and 1 and 2 weeks following consumption

  • Transferrin

    Baseline and 1 and 2 weeks following consumption

  • Hemoglobin

    Baseline and 1 and 2 weeks following consumption

  • Hematocrit

    Baseline and 1 and 2 weeks following consumption

  • Mean Corpuscular Volume

    Baseline and 1 and 2 weeks following consumption

Study Arms (2)

Regular Rice

OTHER

2 servings per day of non-fortified rice

Other: Non-fortified rice

Iron-fortified Rice

OTHER

2 servings per day of Rice enriched in iron for women with iron-deficient anemia to restore their blood counts more efficiently than the standard rice not enriched with iron.

Other: Iron-fortified Rice

Interventions

Non-fortified riceOTHER

Consumption of 2 servings of Non-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.

Regular Rice
Iron-fortified RiceOTHER

Consumption of 2 servings of Iron-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.

Iron-fortified Rice

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Are a healthy woman.
  • Are between 18 and 50 years of age.
  • Have iron deficient anemia.

You may not qualify if:

  • Are pregnant or nursing.
  • Are taking a medication or supplement to treat iron deficiency.
  • Treatment for iron deficiency within the past month
  • Type 1 or type 2 diabetes
  • Ongoing cancer
  • Active auto-immune disease
  • Chronic infections (e.g. HIV/AIDS, hepatitis B, hepatitis C)
  • Chronic kidney disease
  • Liver cirrhosis
  • History of drug or alcohol abuse within the past 6 months
  • History of eating disorder within the past 6 months
  • Any gastrointestinal surgery affecting nutrient absorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Losso JN, Karki N, Muyonga J, Wu Y, Fusilier K, Jacob G, Yu Y, Rood JC, Finley JW, Greenway FL. Iron retention in iron-fortified rice and use of iron-fortified rice to treat women with iron deficiency: A pilot study. BBA Clin. 2017 Sep 8;8:78-83. doi: 10.1016/j.bbacli.2017.09.001. eCollection 2017 Dec.

    PMID: 28966915RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Frank L. Greenway, MD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 7, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

US(1)