Trial record 10 of 184 for:
Open Studies | "Iron"
Pilot Study of the Effect of Iron Fortified Rice in Iron Deficient Anemic Women
This study is currently recruiting participants.
Verified May 2013 by Pennington Biomedical Research Center
Sponsor:
Pennington Biomedical Research Center
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: May 16, 2013
Last verified: May 2013
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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: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
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: | May 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pennington Biomedical Research Center:
|
Iron deficiency anemia rice |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Iron Metabolism Disorders Anemia Deficiency Diseases Hematologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic |
Metabolic Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013