Iron deficiency in sickle cell disease

Not Applicable

Conditions: Health Condition 1: D571- Sickle-cell disease without crisis

Registration Number: CTRI/2024/01/061216

Lead Sponsor: ICMR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

1. Received iron supplements < 3 months prior to recruitment

2. H/o BTx in < 3 months prior recruitment, H/o repeated transfusion = 5 units

3. Severe anemia Hb < 7gm/dL

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br/ ><br>Any adverse effects of iron therapy will be monitored. <br/ ><br>Timepoint: initially monthly and then 3 months and 6 months