Health Condition 1: D50- Iron deficiency anemia
Conditions
Interventions
Intervention1: Livogen Z® tablets
: Dose: 1 Tablet twice daily,
Duration - 90 days (3 months)
Route: Oral,
Fixed Dose Combination consist of:
Ferrous Fumarate IP - 152 mg
Equivalent to 50 mg elementa
Sponsors
Procter and Gamble Health Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects with known IDA as per WHO criteria to whom Livogen Z® will be prescribed per routine clinical practice of the investigator. IDA as per WHO criteria 1. Non-Anemia (g. dL) a. Non-pregnant women (age > 15 years or above) = 12 or higher b. Pregnant women (age > 15 years or above) = 11 or higher 2. Anemia (g. dL) A. Non-pregnant women (age > 15 years or above) a. Mild (Non-pregnant women) 11 to 11.9 b. Moderate (Non-pregnant women) 8 to 10.9 c. Severe (Non-pregnant women) Lower than 8 B. Pregnant women (age > 15 years or above) a. Mild (Pregnant women) 10 to 10.9 b. Moderate (Pregnant women) 7 to 9.9 c. Severe (Pregnant women) 2. Subjects willing to provide written informed consent 3. Subject aged > 18 to = 55 years 4. Subjects willing to comply with the prescribed treatment regimen for the duration of study participation.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they meet any of the following criteria: 1. Subjects with a severe case of anemia requiring blood transfusions. 2. Subjects with anemia, which in the opinion of the investigator is caused by known conditions other than dietary deficiency including: a. Pernicious anemia b. Thalassemia c. Sickle cell or aplastic anemia d. Active peptic ulcer e. Regional enteritis f. Ulcerative Colitis g. Hemorrhoids h. Esophageal varices i. Helminthiasis j. Megaloblastic anemia k. Porphyria cutanea tarda 3. Subjects with folate dependent tumours. 4. Subjects with serious gastrointestinal disorders,(e.g., inflammatory bowel disease, intestinal strictures and diverticulae), who cannot take iron therapy by mouth. 5. Subjects with any known autoimmune disease. 6. Malnourished subjects who also have a known underlying infection that interferes with iron absorption. 7. Subjects with primary or secondary hemochromatosis or who are known to have a risk for iron overload. 8. Subjects with IDA in whom oral therapy has failed in clinical practice. 9. Subjects with an acute bleeding condition. 10. Subjects who have become pregnant with assisted reproduction technology (like In-vitro Fertilization (IVF), etc.) 11. Pregnant subjects in their third trimester gestation week 27 onwards. 12. Pregnant subjects with gestational diabetes or hypertension. 13. Subjects with bleeding disorders. (e.g. blood dyscrasia, subjects with hemophilia, thrombocytopenia, low platelets, coagulopathy, etc.) 14. Subjects suffering from severe or uncontrolled systemic or metabolic diseases. 15. Pregnant subjects with multifetal pregnancy. 16. Subjects who have taken hematinic agents (except Livogen Z®) /supplements continuously for two weeks with a daily dose of elemental iron =27 mg in pregnant subjects, =18mg in non-pregnant subjects and within 4 weeks prior to study start. 17. Subjects with severe concurrent illness (cardiovascular, renal, hepatic), and with any other condition that in the opinion of the investigator does not justify the inclusion of the subject in the study. 18. Subject whose lifestyle (including diet and food intake) would, in the Investigator’s judgment, affect the subject’s participation in the study. 19. Subjects who have participated in any other clinical trial in the past 30 days from the study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin concentration from baseline visit (Visit 1)Timepoint: 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of adverse events, GI tolerability and product acceptability. Timepoint: EOS;Change from baseline (Visit 1) in serum ferritin concentration at EOS.Timepoint: EOS;Change in hemoglobin concentration from baseline visit (Visit 1)Timepoint: Days 21±7, and 60 ± 3 days | — |
Countries
India
Contacts
Public ContactDr Poonam Sule
Procter & Gamble Health Limited
Outcome results
None listed