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

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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Other: Non-fortified rice; Other: Iron-fortified Rice

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Regular Rice; 2 servings per day of non-fortified rice	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.
OTHER: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: The Wright Group in Crowley, LA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: July 30, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (ESTIMATE): August 7, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Iron deficiency anemia; rice
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: PBRC 12026