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

Sponsors

Lead Sponsor: Pennington Biomedical Research Center

Collaborator: The Wright Group in Crowley, LA

Source Pennington Biomedical Research Center
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.

Overall Status Completed
Start Date July 2012
Completion Date October 2015
Primary Completion Date August 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in reticulocyte count. Baseline and 1 and 2 weeks following consumption of 2 servings
Secondary Outcome
Measure Time Frame
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
Enrollment 17
Condition
Intervention

Intervention Type: Other

Intervention Name: Non-fortified rice

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.

Arm Group Label: Regular Rice

Intervention Type: Other

Intervention Name: Iron-fortified Rice

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.

Arm Group Label: Iron-fortified Rice

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Frank L. Greenway, MD Principal Investigator Pennington Biomedical Research Center
Location
Facility: Pennington Biomedical Research Center
Location Countries

United States

Verification Date

October 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Pennington Biomedical Research Center

Investigator Full Name: Frank Greenway

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Regular Rice

Type: Other

Description: 2 servings per day of non-fortified rice

Label: Iron-fortified Rice

Type: Other

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov