A Double Blind Randomised Controlled Trial to Investigate the Effect of Vitamin D3 Supplementation on Iron Absorption and Hepcidin Response in Marginally Deficient and Iron Deficient Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Ferritin Concentration from Baseline to 8 weeks
研究概览
简要总结
Iron is one of the most vital elements in humans as it plays a role in physiological functions such as transferring and storing oxygen, transporting electrons and catalysing numerous reactions, from oxidative metabolism to cellular proliferation. Iron deficiency can be attributed to poor absorption that leads to insufficient iron to meet body requirements. Oral iron supplements have been extensively used to treat iron deficiency and iron deficiency anaemia. However, the use of iron compounds in fortifying foods is one of the best practical approach to combat iron deficiency, while improving diet and food pattern involves long-term goal which can be challenging. Vitamin D has recently been shown to affect hepcidin levels, which in turn has effects on iron status but there are a limited number of studies investigating the hepcidin profile in humans following iron supplementation, and few data are available, especially in humans, despite its role as a primary iron absorption and homeostasis regulator. Although several studies have been carried out using iron fortified products, there is limited data on the potential effect of vitamin D on iron metabolism amongst iron deficient women in particular. Therefore, the present study aims to investigate the effect of vitamin D3 supplementation (1500 IU) consumed with iron fortified breakfast cereals on haematological indicators and hepcidin response in iron deficient women.
详细描述
Recruitment And Sampling Strategy :
Participants will be recruited within the University of Chester, UK only. Emails and posters/leaflets will be used as a medium of advertisement to the target group (staff and students). A total of 62 pre-menopausal women aged between 19 to 40 years old will be included in the study based on criteria described below. Eligibility will be based upon serum ferritin and also vitamin D concentrations at screening before the start of the study. Participants will be required to complete a screening questionnaire which will provide information about participant's health status, drugs/medication/supplement usage, and recent occurrences of illness/trauma/injury. A 6 ml venous blood will be drawn to assess concentrations of plasma ferritin vitamin D, haemoglobin and full blood counts, Participants with plasma ferritin concentrations below 20.0 µg/L and vitamin D concentration below 250 nmol/l will be included in the study. If the levels of haemoglobin are found to be in severe stage of anaemia, the potential participant will be notified and advised to consult their General Practitioner (GP) (haemoglobin levels < 8.0 g/dL). All eligible participants will be briefed on the study protocol before the beginning of the study, and the eligible participants will be given a Participant Information Sheet (PIS) and asked to provide written informed consent.
An 8 week, double blind, randomised controlled trial will be carried out in Chester, United Kingdom (UK). The 8 week intervention period was selected since more than 1 month is appropriate to generally enlarge the erythropoietic marrow and observe changes in red blood cell indices, especially in non-anaemic groups. Most vitamin D studies have used a supplement concentration of 1000 IU and reported no adverse effects in the participants. Some studies have used higher doses of 1600 or 4000 IU with no reported adverse outcomes in the participants.
Participants will be randomly allocated to 2 groups:
- Fe group (iron fortified breakfast cereals and placebo)
- Vitamin D group (iron fortified breakfast cereals and vitamin D3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 19-49 years;
- •non-pregnant nor lactating;
- •serum ferritin levels less than 20 ug/l and vitamin D concentration below 250 nmol/l.
排除标准
- •history of gastrointestinal and metabolic disorders;
- •have donated blood in the past 6 months;
- •regularly consuming nutritional supplements;
- •haemoglobin levels less than 8.0 g/dL.
研究组 & 干预措施
Vitamin D3 supplement
Participants will be asked to take 1 capsule of vitamin D3 supplement (1500 IU) (37.5ug) daily for a total duration of 8 weeks.
干预措施: Vitamin D3 supplement (Dietary Supplement)
Placebo
Participants will be asked to take 1 capsule of placebo (65% olive oil) daily for a total duration of 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Ferritin Concentration from Baseline to 8 weeks
时间窗: 0 and 8 weeks
Blood biomarker of iron stores measured in plasma samples by Mini Vidas Biomerieux
次要结局
- Change in Vitamin D Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Calcium Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Full Blood Count Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Haemoglobin Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Hepcidin Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Parathyroid Hormone (PTH) Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Vitamin D Receptor (VDR) Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Ferritin Concentration from Baseline to 8 weeks(0,4,8 weeks)
- Change in Calcitriol Concentration from Baseline to 8 weeks(0,4,8 weeks)