Assessment of iron deficiency anemia and role of iron therapy in sickle cell disease patients: A prospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
IDA in SCD is multifactorial resulting from ongoing haemolysis, chronic inflammation and micronutrient deficiency. It is presumed that IDA is uncommon in SCD because of recirculation of iron from ongoing hemolysis and blood transfusions patients receive. Various studies mentioned its significant prevalence from 28-67%. Recent study in SCD-pregnant women from Orrisa revealed high/elevated iron stores in them. Diagnosing IDA in SCD is challenging due to elevated ferritin levels and coinheritance of α-thalassemia causing hypochromic-microcytosis. So, IDA can often go unnoticed/underdiagnosed. Murine models showed iron-restricted diet helped in reducing crisis-episodes with potential benefit in reducing organ damages. Thus, some important clinical questions remain to be answered for optimum management of IDA viz. appropriate diagnosis and role of iron therapy.
Novelty:
-
Exact prevalence of IDA in Indian SCD will be calculated after correct diagnosis.
-
Role of iron therapy will be established as many clinicians avoid it in fear of toxicity.
Objectives:
1. To measure prevalence of IDA in SCD
2. To corelate clinical features and complications in SCD patients with their iron status
3. To understand effect of iron therapy on clinical manifestations and Hb-levels in SCD patients with IDA
Methods:
It will be a prospective study. Using various laboratory investigations correct estimate of IDA in Indian SCD will be calculated and diagnosed patients will be prescribed oral iron therapy and followed up for response.
Expected outcome:
**1.**Exact prevalence of IDA in Indian SCD will be calculated.
2. Role of various laboratory investigations for correct diagnosis will be proposed.
3. Early diagnosis and interventions will help to combat deleterious complications of anemia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in steady state, i.e. absence of clinical features of acute illness for at least 4 weeks prior to recruitment
- •Confirmed for SCD-HbSS based on HPLC reports and molecular analysis
- •Clinically having complaints of anemia (fatigue, weakness, lethargy, poor appetite, pica, reduced development and physical performance) and not having any symptoms but HbSS
- •Those on Hydroxyurea (HU).
排除标准
- •Received iron supplements < 3 months prior to recruitment
- •H/o BTx in < 3 months prior recruitment, H/o repeated transfusion ≥ 5 units
- •Severe anemia Hb< 7gm/dL
- •Patients on iron chelation therapy, patients in acute crises
- •Other diagnosed hemolytic diseases: thalassemia, G6PD deficiency, malaria, dengue
- •Raised CRP (> 5 mg/l), liver disease, clinically suspected hepatic disease
- •Diagnosed malignancy
- •Another micronutrient deficiency viz B12, folate/B9
- •Denial of consent
- •Non-compliant to Iron therapy.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)