Health Condition 1: D571- Sickle-cell disease without crisis
Conditions
Interventions
Control Intervention1: Nil: Nil
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in steady state, i.e. absence of clinical features of acute illness for at least 4 weeks prior to recruitment 2. Confirmed for SCD-HbSS based on HPLC reports and molecular analysis 3. Clinically having complaints of anemia (fatigue, weakness, lethargy, poor appetite, pica, reduced development and physical performance) and not having any symptoms but HbSS 4. Those on Hydroxyurea (HU)
Exclusion criteria
Exclusion criteria: 1. Received iron supplements 2. H/o BTx in 3. Severe anemia Hb 4. Patients on iron chelation therapy, patients in acute crises 5. Other diagnosed hemolytic diseases: thalassemia, G6PD deficiency, malaria, dengue 6. Raised CRP ( > 5 mg/l), liver disease, clinically suspected hepatic disease 7. Diagnosed malignancy 8. Another micronutrient deficiency viz B12, folate/B9 9. Denial of consent 10. Non-compliant to Iron therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Iron deficiency in SCD patients based on hematological parameters and surrogate markers will be done and improvement in Hb levels by at least 2gm/dL at the end of therapy; observed after 3 months and 6 months of daily dose.Timepoint: Assessment of Iron deficiency in SCD patients based on hematological parameters and surrogate markers will be done and improvement in Hb levels by at least 2gm/dL at the end of therapy; observed after 3 months and 6 months of daily dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of this iron therapy in clinical features viz, no pain crisis episodes, VOCs, c/o fatigue, hemolysis episodes and jaundice at end of therapy. And those achieving normal iron indices such as sr. iron, sr. ferritin, TIBC, and TS and MCV, MCH, MCHC. Any adverse effects of iron therapy will be monitored. Timepoint: initially monthly and then 3 months and 6 months | — |
Countries
India
Contacts
Public ContactDr. Anand Bodade
ICMR CRMCH under ICMR NIIH
Outcome results
None listed