Fam-D-Bread: A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Serum concentrations of 25-hydroxyvitamin D (25(OH)D)
研究概览
简要总结
Vitamin D deficiency is common. It is caused by limited sun availability together with a low supply of vitamin D in the food system. There is a high prevalence of low vitamin D status around the world. In Ireland, our relatively northern latitude and prevailing weather mean that UVB availability for skin synthesis of vitamin D is limited in this country and our population relies on the dietary supply of vitamin D to prevent deficiency. Thus, the endemic Irish problem of vitamin D malnutrition is due to the lack of vitamin D in our food system. Dietary guidelines cannot address this issue because foods naturally rich in vitamin D are very few and infrequently consumed.
The FamDBread study will test the hypothesis that a vitamin D-fortified bread as part of a healthy diet that includes vitamin D-fortified foods is effective in preventing low vitamin D status during winter, and safe for families to consume.
详细描述
This randomised controlled dietary intervention study aims to recruit households/families of children, teens and adults, with 128 participants who will be randomised to receive vitamin D-fortified bread and advice to consume additional commercially available fortified foods (Treatment group) or identical unfortified bread and advice to consume additional commercially available fortified foods (Control group). The outcome of the study is to test whether increasing vitamin D intake through food (Treatment group) is sufficient to prevent wintertime vitamin D deficiency (measured using serum concentrations of 25-hydroxyvitamin D <30 nmol/L) in comparison with the Control group.
The target vitamin D intake for the treatment group in this study is >20 μg/ day vitamin D. This will maintain serum concentrations of 25-hydroxyvitamin D (25(OH)D) (the biomarker of vitamin D status) > 30 nmol/L, the clinical deficiency threshold to prevent metabolic bone disease, in over 90% of participants. At this vitamin D intake level, about 80% of participants will have a 25(OH)D concentration > 50 nmol/L, the personal intake target in the US and EU.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent if over 16 years; informed parental consent for children under-16 years, plus age-appropriate assent for children under-16 years.
- •Be a household with at least one adult ≥18 years, with at least one dependent aged 5 years or older.
- •Willing to consume bread provided and have storage capacity for frozen bread.
- •Be in good general health.
- •Be willing to follow the assigned diet for 8 weeks and attend the required appointments.
排除标准
- •Daily consumption of a vitamin D supplement with a dose exceeding >10µg/d (400 IU) equivalent.
- •Exposure to factors that may influence vitamin D status, such as winter sun holiday, ski holiday, tanning beds etc.
- •Are following a medically prescribed diet.
- •Have a diagnosis of a medical condition that may interfere with vitamin D absorption, such as Coeliac disease, Inflammatory Bowel Disease, cystic fibrosis, or metabolism, such as liver disease, renal disease.
- •Have a history of active cancer or a diagnosis of cancer within the past 5 years.
- •Have an allergy to the bread ingredients.
- •Are participating in another research study with an intervention or other lifestyle programme that would interfere with the outcomes of the study.
- •Are unable to read, write, or understand English.
研究组 & 干预措施
Fortified bread Intervention group
Fortified bread Intervention group will be supplied with vitamin D fortified bread. Fortified Bread Intervention group will be supplied with fortified bread delivering >20μg vitamin D3 in a daily portion and will receive dietary advice to incorporate fortified foods that are commonly available on the market in their diet.
干预措施: Fortified Bread (Other)
Placebo Comparator
Control arm will receive unfortified bread and dietary advice to incorporate fortified foods that are commonly available on the market in their diet.
干预措施: Unfortified bread (Other)
结局指标
主要结局
Serum concentrations of 25-hydroxyvitamin D (25(OH)D)
时间窗: 8 weeks
Comparison of the number of participants with low vitamin D status (e.g. \<30 nmol/L and \< 50 nmol/L serum 25(OH)D) between treatment and placebo groups
次要结局
- Vitamin D intakes(8 weeks)
- Serum concentrations of albumin-corrected serum calcium concentrations as a safety measure(8 weeks)
- Circulating biomarkers of metabolic health status(8 weeks)
研究者
Mairead Kiely PhD
Professor
University College Cork