Iron Deficiency AnemiaNCT01658488
Pilot Study of the Effect of Iron Fortified Rice in Iron Deficient Anemic Women
A study testing Non-fortified rice and Iron-fortified Rice in people with Iron Deficiency Anemia, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Non-fortified rice and Iron-fortified Rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Are a healthy woman.
- Are between 18 and 50 years of age.
- Have iron deficient anemia.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Pilot Study of the Effect of Iron Fortified Rice on Iron Stores and Reticulocytes 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.
Read the 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.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Non-fortified rice, Iron-fortified Rice
- Keywords
- Iron deficiency anemia, rice
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-fortified riceOther
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 RiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Regular Rice | Other | 2 servings per day of non-fortified rice Receives: Other: Non-fortified rice |
| Iron-fortified Rice | Other | 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. Receives: Other: Iron-fortified Rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reticulocyte count.
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.
Measured: Baseline and 1 and 2 weeks following consumption of 2 servings
Secondary outcomes (5)
Changes in serum iron
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.
Measured: Baseline and 1 and 2 weeks following consumption
Transferrin
Changes in transferrin (a protein that transports iron in the body ) in the fortified rice group compared to the regular rice group.
Measured: Baseline and 1 and 2 weeks following consumption
Hemoglobin
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.
Measured: Baseline and 1 and 2 weeks following consumption
Hematocrit
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.
Measured: Baseline and 1 and 2 weeks following consumption
Mean Corpuscular Volume
Changes in mean corpuscular volume (the average red blood cell size in the fortified rice group compared to the regular rice group.
Measured: Baseline and 1 and 2 weeks following consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Wright Group in Crowley, LA
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank L. Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658488
- Sponsor's protocol ID
- PBRC 12026
- Status last verified
- Oct 2018
- First submitted
- 30 Jul 2012
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28966915
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Iron Fortified Rice on Iron Stores and Reticulocytes in Iron Deficient Anemic Women
- ClinicalTrials.gov ID
- NCT01658488
- Acronym / sponsor ID
- PBRC 12026
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron deficiency anemia, rice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- The Wright Group in Crowley, LA
- Study start
- Jul 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Rice | Other | Other: Non-fortified rice2 servings per day of non-fortified rice |
| Iron-fortified Rice | Other | Other: Iron-fortified Rice2 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Are a healthy woman.
- Are between 18 and 50 years of age.
- Have iron deficient anemia.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-fortified riceConsumption 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. | Other | Regular Rice |
| Iron-fortified RiceConsumption 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. | Other | Iron-fortified Rice |
Primary outcome
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.
5 secondary outcomes
Changes in serum iron
Time frame: Baseline and 1 and 2 weeks following consumption
Transferrin
Time frame: Baseline and 1 and 2 weeks following consumption
Hemoglobin
Time frame: Baseline and 1 and 2 weeks following consumption
Hematocrit
Time frame: Baseline and 1 and 2 weeks following consumption
Mean Corpuscular Volume
Time frame: Baseline and 1 and 2 weeks following consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Results publication: PubMed 28966915Losso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank L. Greenway, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-fortified rice and Iron-fortified Rice in people with Iron Deficiency Anemia, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reticulocyte count. (time frame: Baseline and 1 and 2 weeks following consumption of 2 servings). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01658488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.