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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pennington Biomedical Research Center
Sponsor:
Collaborator:
The Wright Group in Crowley, LA
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01658488
First received: July 30, 2012
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Iron Deficiency Anemia
Other: Non-fortified rice
Other: Iron-fortified Rice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Iron Fortified Rice on Iron Stores and Reticulocytes in Iron Deficient Anemic Women

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Change in reticulocyte count. [ Time Frame: Baseline and 1 and 2 weeks following consumption of 2 servings ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1 and 2 weeks following consumption ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1 and 2 weeks following consumption ] [ Designated as safety issue: No ]
    Changes in transferrin (a protein that transports iron in the body ) in the fortified rice group compared to the regular rice group.

  • Hemoglobin [ Time Frame: Baseline and 1 and 2 weeks following consumption ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1 and 2 weeks following consumption ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1 and 2 weeks following consumption ] [ Designated as safety issue: No ]
    Changes in mean corpuscular volume (the average red blood cell size in the fortified rice group compared to the regular rice group.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658488

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Frank Greenway    225-763-3000    doctors@pbrc.edu   
Contact: Recruiters    225-763-3000    recruiters@pbrc.edu   
Principal Investigator: Frank L. Greenway, MD         
Sub-Investigator: Jennifer Rood, PhD         
Sub-Investigator: John Finley, PhD         
Sub-Investigator: Jack Losso, PhD         
Sponsors and Collaborators
Pennington Biomedical Research Center
The Wright Group in Crowley, LA
Investigators
Principal Investigator: Frank L. Greenway, MD Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01658488     History of Changes
Other Study ID Numbers: PBRC12026
Study First Received: July 30, 2012
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Iron deficiency anemia
rice

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014