The impact of chronic inflammation on long term iron absorption in women of reproductive age with Human Immunodeficiency Virus Infection using iron isotope dilution method A cohort study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quantitative estimate of the difference in long term iron balance due to effect of HIV induced chronic inflammation in WRA with HIV infection as compared to healthy controls.
研究概览
简要总结
Study objective:
To compare the effect of chronic inflammation on long-term iron absorption, between WRA with and without HIV infection using the stable iron isotope dilution technique over 6 months.
Study Design:
2 arm prospective cohort study
Outcomes:
-
Quantitative estimate of the difference in long term iron balance due to effect of HIV induced chronic inflammation in WRA with HIV infection as compared to healthy controls.
-
Labelled cohort that allows for subsequent testing of iron supplement interventions or absorption enhancers
Sample size: n=40, 20 in each arm
Recruitment: 1 year; Follow-up: for 1.5 years
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •WRA with HIV infection Known HIV positive status and stable on ART who are: Non pregnant (negative on urine pregnancy test), non-lactating WRA, Hb more than 11g/dL, Corrected serum ferritin more than 50mcg/L, CRP more than 5mg/L.
排除标准
- •Healthy control WRA History of -Major illnesses or blood transfusion in the last three months prior to study -Current anticoagulation use, for any indication -Menorrhagia for preceding 3 months -Other chronic inflammatory states/ diseases.
- •Diabetes Mellitus, Rheumatoid arthritis, chronic obstructive pulmonary disease, severe obesity, Inflammatory bowel disease, ischemic heart disease, malignancy and Chronic liver disease. WRA with HIV infection -Same as those for healthy control WRA and -Opportunistic infections (OI) requiring hospitalisation or treatment of more than a week in the last three months prior to study.
结局指标
主要结局
Quantitative estimate of the difference in long term iron balance due to effect of HIV induced chronic inflammation in WRA with HIV infection as compared to healthy controls.
时间窗: 18 months
次要结局
- Labelled cohort that allows for subsequent testing of iron supplement interventions or absorption enhancers(18 months)
研究者
Savitha Anne Sebastian
St Johns Medical College, Bengaluru