DefinePK

Research Objective

To establish the effectiveness and side effects of parenteral iron therapy compared to oral iron therapy in children with Iron Deficiency Anemia (IDA).

Methodology

A randomized controlled trial conducted at Combined Military Hospital (CMH) Quetta from January 2023 to December 2023. 400 children aged 2-12 years with IDA were recruited and stratified by age and gender, then allocated to receive either oral ferrous sulfate or parenteral iron sucrose. Hemoglobin, ferritin, and transferrin saturation levels were measured at baseline and at six weeks. Compliance and side effects were also assessed. Data was analyzed using SPSS version 26.

Methodology Flowchart

                        graph TD
    A[Recruit 400 children with IDA 2-12 yrs] --> B[Randomize into two groups];
    B --> C[Oral Iron Therapy Group Ferrous Sulfate];
    B --> D[Parenteral Iron Therapy Group Iron Sucrose];
    C --> E[Administer oral ferrous sulfate for 6 weeks];
    D --> F[Administer parenteral iron sucrose over scheduled doses];
    E --> G[Collect data: Hemoglobin, Ferritin, Transferrin Saturation, Compliance, Adverse Effects at baseline and 6 weeks];
    F --> G;
    G --> H[Analyze data using SPSS v26];
    H --> I[Compare outcomes between groups];
    I --> J[Draw Conclusions];                    

Discussion

Parenteral iron therapy demonstrated superior efficacy in achieving hemoglobin normalization and replenishing iron stores compared to oral iron therapy in children with IDA. The higher compliance rates with parenteral iron, attributed to bypassing gastrointestinal issues, contribute to its effectiveness. While both therapies were generally safe, parenteral iron showed a more favorable side effect profile with fewer gastrointestinal disturbances. The study suggests parenteral iron therapy is a viable alternative when oral iron is poorly tolerated or adherence is an issue, especially when rapid correction of anemia is desired.

Key Findings

Parenteral iron therapy resulted in a higher rate of hemoglobin normalization (95%) compared to oral iron therapy (75%) (p<0.001). The mean hemoglobin rise was also significantly greater in the parenteral group (3.5 ± 1.2 g/dL) than the oral group (2.1 ± 1.0 g/dL) (p < 0.001). Compliance was significantly higher in the parenteral group (98%) versus the oral group (60%) (p<0.001). Gastrointestinal side effects were reported in 20% of the oral group, while 5% of the parenteral group experienced mild transient hypotension.

Conclusion

Parenteral iron therapy is more effective and has better adherence rates with a favorable safety profile compared to oral iron therapy in children with IDA. It leads to higher hemoglobin normalization rates and is recommended for cases where oral iron is not well tolerated or adherence is poor, optimizing treatment outcomes and child health.

Fact Check

1. Sample Size: 400 children were recruited for the study.
2. Hemoglobin Normalization Rate: 95% of patients in the parenteral group achieved hemoglobin normalization compared to 75% in the oral group.
3. Adherence Rate: 98% adherence was observed in the parenteral group versus 60% in the oral group.

Mind Map