Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Ferritin levels (ng/mL) increase > 95% compared to basal levels
研究概览
简要总结
Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. These patients are usually premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not balanced.
The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not tolerated, and a dietary approach through a iron-rich diet in this subset of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Celiac patients on gluten free diet since 1 year
- •iron deficiency (ferritin <15 ng/L or ferritin 15-20 + transferrin saturation <15%)
排除标准
- •allergy to iron supplementation
- •pregnancy or breastfeeding
- •menopause
- •organic or psychiatric diseases
研究组 & 干预措施
Iron sulfate 105 mg
Iron sulfate 105 mg: 1 pill/day is administered
干预措施: Iron sulfate 105 mg (Drug)
Iron-rich diet
Iron-rich diet recommendations are given
干预措施: Iron-rich diet (Dietary Supplement)
结局指标
主要结局
Ferritin levels (ng/mL) increase > 95% compared to basal levels
时间窗: 12 weeks
次要结局
- Hemoglobin levels (g/dL), compared to basal levels(12 weeks)
- Iron levels (mcd/dl), compared to basal levels(12 weeks)
- Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels(12 weeks)
研究者
Francesca Ferretti, MD
MD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico