Fe-minine Health and Exercise
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Ferritin blood test
研究概览
简要总结
The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years for 8 weeks. The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system. Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate. Study parameters are blood tests (fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP) and Body height and weight as well as questionnaires.
详细描述
Aim The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years.
Methods The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system.
Recruitment and participation criteria Individuals will be recruited through any or all of the following: at primary care center(s) in Sweden, via posters at the care center(s), via care providers during visits to the care center(s) and/or via external advertisement through social media and/or at public spaces.
Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise. As reimbursement, participants will receive 2000 SEK for the drawing of blood samples at the end of their study participation.
Inclusion visit
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise.
排除标准
- •Significant disease affecting inflammation and/or hemoglobin levels. Inability to cooperate or to fill out questionnaires.
结局指标
主要结局
Ferritin blood test
时间窗: From enrollment to end of test period, 8 weeks.
Change (increase) in serum ferritin levels.
次要结局
- Changes in measures of hemoglobin(From enrollment to end of test period, 8 weeks.)
- Sense of well being and subjective sense of health(From enrollment to end of test period, 8 weeks.)
研究者
Fredrik H Nystrom
MD PhD full professor, senior consultant in internal medicine
University Hospital, Linkoeping