Acute Effect of Vitamin D3 Supplementation on Serum 25(OH)D
试验速览
- 阶段
- 不适用
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in serum 25(OH)D
研究概览
简要总结
The investigators have previously completed a clinical trial with long-term vitamin D3 supplementation in healthy humans during a season with negligible ultraviolet B radiation (UVB) in terms of serum 25-hydroxy vitamin D (25(OH)D) increase. In this study (submitted, unpublished), a temporary increase was identified during the first three weeks. Individually, this temporary increase was found in 14 out of 19 participants. This phenomenon has not been described elsewhere in the literature. This could be possible due to less frequent sampling.
The investigators hypothesized that this phenomenon is actual and not an artefact.
The aim of this study was to investigate the serum 25(OH)D increase after short-term vitamin D3 supplementation in a new group of healthy participants with more frequent 25(OH)D sampling. Furthermore, to investigate the influence of sex, age, weight, height, body mass index (BMI), number of fatty fish meals per week, 25(OH)D start level and 30 genetic parameters.
This is a single-centre, open and non-blinded clinical trial. No randomisation was used, as all participants received identical treatment. 25(OH)D sampling was increased from once a week to twice a week. Demographic data (gender, age, weight, height) was collected/measured and registered in prior to study start. The number of daily consumed fatty fish meals was recorded in a questionnaire.
详细描述
Background The investigators have previously completed a clinical trial with long-term vitamin D3 supplementation in healthy humans during a season with negligible UVB in terms of serum 25-hydroxy vitamin D (25(OH)D) increase. In this study (submitted, unpublished), a temporary increase was identified during the first three weeks. Individually, this temporary increase was found in 14 out of 19 participants. This phenomenon has not been described elsewhere in the literature. This could be possible due to less frequent sampling.
Study hypothesis The investigators hypothesized that this phenomenon is actual and not an artefact. As this phenomenon was not present in all participants, the investigators also hypothesized that influential parameters could include sex, age, weight, height, body mass index (BMI), number of fatty fish meals per week, 25(OH)D start level and genetic parameters (30 pigment single nucleotide polymorphisms (SNP)).
Study design This is a single-centre, open and non-blinded clinical trial.
Intervention Participants will receive packages containing sufficient vitamin D3 tablets (Cholecalciferol, Apovit, Takeda Pharma A/S, Roskilde, Denmark) to cover the consumption corresponding to one week. They will be instructed to consume one vitamin D3 tablet per day corresponding to 85 microgram (ug) (3400 international unit (IU)).
Methodological aspects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy participants
- •resident in Denmark
排除标准
- •any supplementary vitamin D intake within three weeks prior to study start
- •use of other supplementary vitamin D than given during the study period;
- •sun holiday south of latitude 45 degree North less than three weeks prior to or during the study period;
- •use of solarium less than three weeks prior to or during the study period;
- •chronic disease;
- •skin disease;
- •intake of cholesterol-lowering medication;
- •pregnancy;
- •drug addiction;
- •psychiatric disorder;
- •physical disabilities;
- •serious adverse events such as hypercalcaemia and nephrolithiasis
研究组 & 干预措施
Vitamin D3 supplementation
All participants will be selected for treatment with cholecalciferol, vitamin D3 supplementation and included in this single arm
干预措施: cholecalciferol, Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change in serum 25(OH)D
时间窗: 3 weeks
Serum 25(OH)D is a marker of vitamin D increase induced by vitamin D3 supplementation
Model of increase in serum 25(OH)D
时间窗: 3 weeks
Model fit of the increase in serum 25(OH)D
次要结局
未报告次要终点
研究者
Pameli Datta
Medical Doctor
Bispebjerg Hospital