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

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Non-fortified rice

Iron-fortified Rice

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Iron deficiency anemia, rice

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Regular Rice

Iron-fortified Rice

Arm Description

2 servings per day of non-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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in serum iron

Changes in serum iron is a medical laboratory test that measures the amount of circulating iron in the blood; in the fortified rice group compared to the regular rice group.

Transferrin

Changes in transferrin (a protein that transports iron in the body ) in the fortified rice group compared to the regular rice group.

Hemoglobin

Changes in hemoglobin (The key protein in red blood cells to which oxygen attaches) in the fortified rice group compared to the regular rice group.

Hematocrit

Changes in hematocrit (the proportion of your total blood volume that is composed of red blood cells) in the fortified rice group compared to the regular rice group.

Mean Corpuscular Volume

Changes in mean corpuscular volume (the average red blood cell size in the fortified rice group compared to the regular rice group.

Full Information

NCT ID

NCT01658488

First Posted

July 30, 2012

Last Updated

October 30, 2018

Sponsor

Pennington Biomedical Research Center

Collaborators

The Wright Group in Crowley, LA

1. Study Identification

Unique Protocol Identification Number

NCT01658488

Brief Title

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

Official Title

Pilot Study of the Effect of Iron Fortified Rice on Iron Stores and Reticulocytes in Iron Deficient Anemic Women

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

The Wright Group in Crowley, LA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

Keywords

Iron deficiency anemia, rice

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regular Rice

Arm Type

Other

Arm Description

2 servings per day of non-fortified rice

Arm Title

Iron-fortified Rice

Arm Type

Other

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Non-fortified rice

Intervention Description

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

Intervention Name(s)

Iron-fortified Rice

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in reticulocyte count.

Description

Time Frame

Baseline and 1 and 2 weeks following consumption of 2 servings

Secondary Outcome Measure Information:

Title

Changes in serum iron

Description

Changes in serum iron is a medical laboratory test that measures the amount of circulating iron in the blood; in the fortified rice group compared to the regular rice group.

Time Frame