Comparison of Intramuscular versus Intravenous Vitamin B12 Supplementation in Children with Severe Acute Malnutrition and Vitamin B12 Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Biochemical vitamin B12 correction at8 days, defined as serum vitamin B 12 morethan 200 pg per mL
研究概览
简要总结
SAM is strongly associated with micronutrient deficiencies ,Particularly vitamin B12.Current WHO and Indian guidelines recommend broad spectrum micronutrients including B12 but lack clarity on optimal administration routes.IM injections are standard but Painful ,risky in Children with low muscle mass.Hence IV Vitamin B12 may be viable alternative,Offering faster bioavailability and fewer Complications,especially in hospitalized SAM Children who already have IV access.However Comparative data on IM Vs IV routes in this population are lacking.Hence,this Study aims to evaluate whether IV B 12 is safer and equally or more effective option in managing SAM with B 12 deficiency.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Infants and children aged 6 months to 5 years who are admitted to the NRC with severe acute malnutrition with vitamin B12 deficiency.
排除标准
- •(1)Hemoglobin lessthan 5 gper dL requiring urgent transfusion (2)Children with SAM who have acute life threatening complications requiring ICU care, (3)Those with known disorders of B12 absorption or metabolism (e.g. short gut, congenital B12 malabsorption), (4)Those who received vitamin B12 injection per oral in the past 3 months.
结局指标
主要结局
Biochemical vitamin B12 correction at8 days, defined as serum vitamin B 12 morethan 200 pg per mL
时间窗: Biochemical vitamin B12 correction at8 days, defined as serum vitamin B 12 morethan 200 pg per mL
次要结局
- Hemoglobin improvement(ii))
研究者
Dr Varsha Patil R
KMCRI , HUBBALLI