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临床试验/NCT05139576
NCT05139576已完成不适用

Practices of Vitamin D Supplementation Leading to Vitamin D Toxicity: Experience From a Tertiary Care Center of a Low Middle Income Country

Aga Khan University Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
186
试验地点
1
主要终点
Potential vitamin D toxicity

研究概览

简要总结

To determine the frequency toxicity (>150 ng/ml) in subjects for 25-hydroxyvitamin D (25OHD) and evaluate the vitamin D (VD) supplements used by these subjects.

详细描述

This prospective cross-sectional study was conducted at the Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, AKUH Karachi Pakistan after approval from Aga Khan University Hospital's Ethics Review Committee (ERC ID: 2019-1973-6924). Data of subjects tested for serum 25OHD between April 2020 to March 2021 was reviewed daily and those with 25OHD levels >150 ng/ml were contacted via telephone. Only the initial results of the subjects tested at Clinical Laboratory were included. Those with incomplete clinical history, 25OHD levels <150ng/ml, whose contact numbers were unavailable or not answering telephone calls were excluded. To maintain confidentiality all identifiers were removed, and study identity numbers were generated.

After explaining the reason for phone call, verbal informed consent was taken and clinical information of calcium and VD supplementation including prescribed or self-medicated, indications for prescription, formulation strength, total dosage, frequency, duration, and calcium status was collected on a structured clinical history forms. The hypercalcemia was labeled when serum calcium was >10.2 mg/dl.

Data analysis:

The statistical analysis was performed using the Microsoft Excel 2016. Subjects were categorized into two age groups: <18 years (pediatric) and ≥18 years (adult). Total doses of VD supplements were added to calculate cumulative supplementation and daily supplementation was calculated by dividing cumulative dose by duration of supplementation.

Descriptive statistics median (interquartile range, IQR) were calculated for numerical data while frequency (percentage) for categorical data. Frequencies of subjects with VD toxicity were derived and their correlates were evaluated in the both the age groups. Demographics (age and gender), calcium status of subjects, indications, formulation strengths, frequency, duration, cumulative and daily dose of supplementation were generated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects WITH serum 25OHD levels >150 ng/ml.
  • Only the initial results.

排除标准

  • Serum 25OHD levels <150ng/ml,
  • Incomplete clinical history
  • Whose contact numbers were unavailable
  • Who were not answering telephone calls

结局指标

主要结局

Potential vitamin D toxicity

时间窗: April 2020 to March 2021

Frequency of potential vitamin D Toxicity and use of VD supplementation including prescribed or self-medicated, indications for prescription, formulation strength, total dosage, frequency and duration will be determined.

次要结局

未报告次要终点

研究者

发起方
Aga Khan University Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Siraj Muneer

Resident

Aga Khan University Hospital, Pakistan

研究点 (1)

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