Pilot Study of the Effect of Iron Fortified Rice in Iron Deficient Anemic Women

NCT ID: NCT01658488

Last Updated: 2018-11-01

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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The study will consist of 1 screening visit and 3 study visits. The two-week study will be scheduled to be between menses.

You will then be assigned to eat regular rice dishes or rice dishes fortified with iron for the two-week period. The assignment to the rice group will be made randomly (like flipping a coin). Your chance of being in either rice group will be 50:50. You will be given 14 frozen rice meals in styrofoam containers to take home. You will be expected to eat two rice dishes per day for the next study week and to bring the empty containers to your next study visit.

Conditions

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Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Regular Rice

2 servings per day of non-fortified rice

Group Type OTHER

Non-fortified rice

Intervention Type OTHER

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.

Iron-fortified Rice

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.

Group Type OTHER

Iron-fortified Rice

Intervention Type OTHER

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.

Interventions

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Non-fortified rice

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.

Intervention Type OTHER

Iron-fortified Rice

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Wright Group in Crowley, LA

UNKNOWN

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank L. Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 28966915 (View on PubMed)

Other Identifiers

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PBRC 12026

Identifier Type: -

Identifier Source: org_study_id

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