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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658488
• Other study ID #: PBRC 12026
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2018
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	The Wright Group in Crowley, LA

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and 1 and 2 weeks following consumption
Secondary	Transferrin	Changes in transferrin (a protein that transports iron in the body ) in the fortified rice group compared to the regular rice group.	Baseline and 1 and 2 weeks following consumption
Secondary	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.	Baseline and 1 and 2 weeks following consumption
Secondary	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.	Baseline and 1 and 2 weeks following consumption
Secondary	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.	Baseline and 1 and 2 weeks following consumption