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Completed

NCT Number: NCT01658488

Pilot Study of the Effect of Iron Fortified Rice 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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-fortified rice

Other

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

Other

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 outcomes

  1. Change in reticulocyte count.

    Time frame: Baseline and 1 and 2 weeks following consumption of 2 servings

    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 outcomes

  1. Changes in serum iron

    Time frame: Baseline and 1 and 2 weeks following consumption

    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.

  2. Transferrin

    Time frame: Baseline and 1 and 2 weeks following consumption

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

  3. Hemoglobin

    Time frame: Baseline and 1 and 2 weeks following consumption

    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.

  4. Hematocrit

    Time frame: Baseline and 1 and 2 weeks following consumption

    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.

  5. Mean Corpuscular Volume

    Time frame: Baseline and 1 and 2 weeks following consumption

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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • The Wright Group in Crowley, LA

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2012
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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