Health Condition 1: D508- Other iron deficiency anemias
Conditions
Interventions
Intervention1: Liposomal Ferric Pyrophosphate (IronnoxTM): Each capsule contains 30 mg of elemental iron, to be taken orally once daily with meals for a duration of 8 weeks.
Intervention2: Liposomal F
Sponsors
Botanic Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 45 years 2. Mild to moderate iron deficiency anaemia (Hb greater than or equal to 8.0 g per dL and less than 12.0 g per dL) 3. Serum ferritin 15 to 30 ng per mL 4. Normal CRP (greater than or equal to 5 mg per L) 5. No iron supplementation in the past 30 days 6. Non-pregnant and non-lactating women
Exclusion criteria
Exclusion criteria: 1. Hb less than 8.0 g per dL or greater than or equal to 12.0 g per dL 2. History of iron hypersensitivity 3. Anaemia due to chronic disease 4. Blood transfusion within 3 months 5. Hepatic or renal dysfunction 6. Postmenopausal women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the change in haemoglobin (Hb) levels 2.To assess the change in serum ferritin levels 3.To measure changes in serum iron and total iron-binding capacity (TIBC) 4.To assess changes in transferrin saturation (TSAT) 5.To evaluate fatigue severity using a fatigue scale.Timepoint: Baseline, week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate gastrointestinal tolerability, including nausea, constipation, and metallic taste. 2.To assess changes in CRP levels during the study. 3.To determine the incidence and nature of adverse events. 4.To assess treatment compliance and patient acceptability.Timepoint: 1.Week 4 and Week 8 2.Baseline and week 8 3.Week 4 and Week 8 4.Week 4 and Week 8 | — |
Countries
India
Contacts
Public ContactDr H N Shivaprasad
Botanic Healthcare Pvt Ltd
Outcome results
None listed