Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01828060
Eligibility Criteria:
Inclusion Criteria:
* 18-65 year old people of either gender
* Borderline anemic (This is compensated for altitude of study location):
* Hemoglobin level at or below 13.5 g/dL(women)
* Hemoglobin level at or below 15.5 g/dL(men)
Exclusion Criteria:
* Known diagnosis with pernicious or other megaloblastic anemias, aplastic, sickle cell, thalassemia, autoimmune hemolytic anemias;
* Known diagnosis with Hashimoto's Disease;
* Known chronic kidney disease;
* Rheumatoid arthritis;
* Splenectomy;
* Serious active illness within past 12 months;
* Active cancer and/or chemotherapy within the last 12 months;
* Major surgery during past 8 weeks;
* Scheduled surgery during study;
* Received blood transfusion during the past 8 weeks;
* Having donated blood for 6 weeks prior to study, or planning to donate blood during the 8 week study;
* Distance athlete;
* Unable to commit to staying on a constant regimen of medication and supplements for the duration of the study, with the exception of changes to medication needed for optimal care;
* Changes to prescription medication within 2 weeks before starting the study;
* Participation in other clinical trials during the month before this study begins;
* Participating in other clinical trials during this study;
* Current use of any dietary supplements that may affect hemoglobin levels; Vitamin B12 (over 500 mcg), Iron (over 100mg), or any other dietary supplement that, in the opinion of the investigator, may affect hemoglobin levels;
* Currently experiencing intense stressful events/ life changes that would negatively affect compliance;
* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is not a problem, including appendix and gallbladder removal);
* Females of child-bearing potential: Pregnant, nursing, or trying to become pregnant;
* Food allergies related to sorghum or rice.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01828060
Study Brief:
Protocol Section:
NCT01828060