Impact of Dose Optimization on Compliance to Iron Folic Acid Supplementation among Adolescent Girls: Open labelled Non-Randomized Controlled Trial at Ahmedabad District, Gujarat
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
研究概览
简要总结
Iron-deficiency anemia remains a major public health concern among adolescent girls in India. As per NFHS-5, nearly 59.1**%** and 69% of adolescent girls aged 15–19 years in India & Gujarat respectively are anaemic. The Weekly Iron and Folic Acid Supplementation (WIFS) program under the National Iron Plus Initiative (NIPI) provides 60 mg elemental iron and 500 mcg folic acid once a week. Despite program implementation, compliance is poor, primarily due to gastrointestinal side effects. Total 400 adolescent girls will be included in the study, out of them 200 will be in study group who will receive biweekly IFA supplementation whereas 200 adolescent girls will be the control group who will receive standard weekly IFA supplementation under National Iron plus initiative. Hemoglobin estimation will be done in the beginning of the study and at the end of 6 months among both groups. Compliance will be ascertained by standard questionnaire and tablets consumption. The compliance rate will be calculated. Compliance will be expressed in percentages. Compliance registers will be filled up by school teachers every weekly. For qualitative insights, FGD (Focused group discussion) sessions in each respective school will be organized regarding compliance of the IFA.
Findings of this open-label non-randomized controlled trial in Ahmedabad district, Gujarat aims to develop specific evidence on whether dose optimization biweekly lower IFA dosage regimen (30 mg iron + 250 mcg folic acid) has any effect on compliance and haemoglobin levels among school going adolescent girls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 14.00 Year(s) 至 19.00 Year(s)(—)
- 性别
- Female
入选标准
- •Adolescent girls in their middle or late adolescent age (14 to 19 years), who herself or whose parents are ready to give written informed assent /consent to participate in the study.
排除标准
- •1.Adolescent girl who will be anemic at the time of baseline assessment.
- •2.Adolescent girl who is already on Iron therapy for treatment of anemia.
- •3.Adolescent girl who is diagnosed with hemoglobinopathies (Sickle cell anemia, Thalassemia major/minor).
- •Adolescent girl who is currently having any kind of systemic illness (Tuberculosis, Diabetes, Hypertension, Thyroid disorders etc.) which requires treatment.
研究者
Dr Venu Shah
GCS Medical College, Ahmedabad
