CTRI/2023/01/048783
Not yet recruiting
未知
Investigation of efficacy and safety of different iron supplementations in nonanemic to mild anemic adults with iron deficiency and suffering from fatigue. - Nil
Meyer Organics Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Meyer Organics Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult male and females with the age between 18\-65 years old (Both inclusive);
- •2\.Subjects presenting with fatigue scoring between 18 to 54 based on\-Fatigue Severity Scale (FSS) at screening;
- •3\.Serum ferritin levels lower than 50 mcg/L (iron deficiency);
- •4\.Hemoglobin levels \=11 g/dL in non\-pregnant women and men (mild anemic to non\-anemic patients, defined by WHO);
- •5\.Subjects with or without comorbidity, if comorbid, should be with stable prescription for last three months;
- •6\.Able to give written informed consent;
- •7\.Able to follow up through visits.
Exclusion Criteria
- •1\.Previous diagnosis of any concurrent disease or medical and/or surgical condition as a possible cause of fatigue or iron deficiency;
- •2\.Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.).
- •3\.Medical history of malabsorption syndrome, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy;
- •4\.Patients who are eligible for IV iron replacement therapy.
- •5\.Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator
- •6\.Any treatment with any vitamin and mineral supplements prior to inclusion to the study in the last 3 months’ period;
- •7\.Participants on dialysis or with an estimated glomerular filtration rate \<30 mL/minute/1\.73 m raise to 2
- •8\.Ongoing or history of malignancy within past 3 years;
- •9\.Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 4 weeks postpartum, or have a positive serum/urine pregnancy test;
- •10\.Known or suspected hypersensitivity to iron or any of the components of investigational products;
Outcomes
Primary Outcomes
Not specified
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