Clinical trial NCT01658488: Pilot Study of the Effect of Iron Fortified Rice in Iron Deficient Anemic Women
Official title: Pilot Study of the Effect of Iron Fortified Rice on Iron Stores and Reticulocytes in Iron Deficient Anemic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia
rice
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: The Wright Group in Crowley, LA
First posted: 2012-08-07
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in reticulocyte count.
timeFrame: Baseline and 1 and 2 weeks following consumption of 2 servings
Secondary outcomes:
measure: Changes in serum iron
timeFrame: Baseline and 1 and 2 weeks following consumption
measure: Transferrin
timeFrame: Baseline and 1 and 2 weeks following consumption
measure: Hemoglobin
timeFrame: Baseline and 1 and 2 weeks following consumption
measure: Hematocrit
timeFrame: Baseline and 1 and 2 weeks following consumption
measure: Mean Corpuscular Volume
timeFrame: Baseline and 1 and 2 weeks following consumption
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L. Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.