Practices of Vitamin D Supplementation Leading to Vitamin D Toxicity
Practices of Vitamin D Supplementation Leading to Vitamin D Toxicity: Experience From a Tertiary Care Center of a Low Middle Income Country
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Sindh
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Karachi、Sindh、パキスタン、3500
- The Aga Khan University
-
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Subjects WITH serum 25OHD levels >150 ng/ml.
- Only the initial results.
Exclusion Criteria:
- Serum 25OHD levels <150ng/ml,
- Incomplete clinical history
- Whose contact numbers were unavailable
- Who were not answering telephone calls
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Pediatric Subjects and adults
Subjects were categorized into two age groups: <18 years (pediatric) and ≥18 years (adult).
|
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.
|
|
Pediatrics and adults
Subjects were categorized into two age groups: <18 years (pediatric) and ≥18 years (adult).
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Potential vitamin D toxicity
時間枠: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.
|
April 2020 to March 2021
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2019-1973-5495
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。