Evaluating the Vitamin K2 Status of Calcium-based Stone Formers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Concentration of blood dp-ucMGP (dephosphorylated-uncarboxylated Matrix Gla Protein)
研究概览
简要总结
This is an observation, single site-study with one study visit during which all data and samples will be collected. Study participants will be asked to provide blood, urine, and fecal samples so that the investigators may study the differences in the gut microbiota, vitamin K2 levels, and other parameters between participants who form kidney stones and those who do not.
详细描述
It is hypothesized that calcium-based stone formers will have an altered fecal gut microbiota compared to non-stone former controls. This altered microbiota will have a lower abundance of bacteria that produce menaquinones (vitamin K2), thus stone formers will also have a different blood menaquinone profile compared to controls. Ultimately, the different levels of menaquinones will result in increased inactive Matrix Gla protein (dp-ucMGP), which is a key protein that sequesters free calcium. To test this hypothesis, calcium-based stone former and non-stone forming controls will be recruited to a single site, observation study to collect urine, blood, and fecal samples. These samples will be used to determine dp-ucMGP levels, menaquinone profiles, the composition of the gut microbiota, and other parameters of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/Female, 18 - 65 years old
- •No self-reported kidney stones during their lifetime (controls)
- •Ultrasound examination confirming absence of kidney stones (controls)
- •Have had at least 1 incidence of a clinically confirmed calcium-based kidney stone in the last 12 months (stone formers)
- •Ability to collect a clean catch urine sample
- •Prescription and over-the-counter drugs unchanged for ≥30 days
- •Willingness to provide medical information, blood, urine, and fecal samples
排除标准
- •Current, or within 30 days, use of antibiotics or antifungals
- •Current, or within 30 days, use of vitamin K antagonists
- •Current probiotic use or any use within 14 days of screening sample collection should be recorded
- •A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy 2021-06-29 1.0 Page 4 of 6
- •Fecal incontinence
- •History of disorder with abnormal calcium regulation such as hyperparathyroidism, active malignancy, or osteoporosis.
结局指标
主要结局
Concentration of blood dp-ucMGP (dephosphorylated-uncarboxylated Matrix Gla Protein)
时间窗: At baseline only
dp-ucMGP will be quantified using an enzyme-linked immunosorbent assay
Concentration of blood undercarboxylated osteocalcin (ucOC)
时间窗: At baseline only
ucOC will be quantified using an enzyme-linked immunosorbent assay
Concentration of urine undercarboxylated osteocalcin (ucOC)
时间窗: At baseline only
ucOC will be quantified using an enzyme-linked immunosorbent assay
Concentration of blood menaquinones (vitamin K2) - MK-7
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
Fecal microbiota composition of stone-formers and controls
时间窗: At baseline only
Fecal samples will be collected using out validated toilet paper method. Microbial DNA will be extracted and sequenced using next-generation sequencing.
Concentration of blood menaquinones (vitamin K2) - MK-4
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
Concentration of blood menaquinones (vitamin K2) - MK-9
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
Concentration of blood menaquinones (vitamin K2) - MK-12
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
Concentration of urine dp-ucMGP (dephosphorylated-uncarboxylated Matrix Gla Protein)
时间窗: At baseline only
dp-ucMGP will be quantified using an enzyme-linked immunosorbent assay
Concentration of blood total osteocalcin (OC)
时间窗: At baseline only
Total OC will be quantified using an enzyme-linked immunosorbent assay
Concentration of blood menaquinones (vitamin K2) - MK-10
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
Concentration of urine total osteocalcin (OC)
时间窗: At baseline only
Total OC will be quantified using an enzyme-linked immunosorbent assay
Concentration of blood menaquinones (vitamin K2) - MK-13
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
Concentration of blood menaquinones (vitamin K2) - MK-8
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
Concentration of blood menaquinones (vitamin K2) - MK-11
时间窗: At baseline only
Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.
次要结局
- Concentration of blood fetuin A(At baseline only)
- Concentration of urinary phosphate(At baseline only)
- Percentage of blood Hemoglobin A1C (HbA1c)(At baseline only)
- Concentration of urinary oxalate(At baseline only)
- Concentration of urine fetuin A(At baseline only)
- Concentration of ionized calcium in blood(At baseline only)
- Concentration of urinary creatinine(At baseline only)
- Concentration of blood albumin(At baseline only)
- Total plasma calcium(At baseline only)
- Concentration of urinary γ-carboxyglutamic acid(At baseline only)
研究者
Jennifer Bjazevic
Principal Investigator, MD
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's