Practices of Vitamin D Supplementation Leading to Vitamin D Toxicity

NCT05139576 | Completed DMC

• 1 other identifier: 2019-1973-5495
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Toxicity

Outcome Measures

Primary Outcomes (1)

• Potential vitamin D toxicity

  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

Study Arms (2)

Pediatric Subjects and adults

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

Diagnostic Test: serum 25OHD testing

Pediatrics and adults

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

Diagnostic Test: serum 25OHD testing

Interventions

serum 25OHD testing 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.

Pediatric Subjects and adults; Pediatrics and adults

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects tested for serum 25OHD

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

The Aga Khan University

Karachi, Sindh, 3500, Pakistan

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 1, 2021
• Study Start: April 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)