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Practices of Vitamin D Supplementation Leading to Vitamin D Toxicity

NCT ID: NCT05139576

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vitamin D Toxicity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Subjects and adults

Subjects were categorized into two age groups: \<18 years (pediatric) and ≥18 years (adult).

serum 25OHD testing

Intervention Type DIAGNOSTIC_TEST

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).

serum 25OHD testing

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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serum 25OHD testing

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Siraj Muneer

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Aga Khan University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2019-1973-5495

Identifier Type: -

Identifier Source: org_study_id