A Pharmacokinetics Study of an Orodispersible vs Soft Gelatin Vitamin D3 Supplement in Vitamin D Deficient Healthy Adults

Conditions: Vitamin D Deficiency

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: 1

Phase: NA

Enrollment: 40

Sponsor: Liaquat University of Medical & Health Sciences

Location: Pakistan

Summary

This is an open-labelled, randomized controlled clinical trial aimed to compare the pharmacokinetics of an orodispersible vs a soft gelatin vitamin supplementation in vitamin D deficient healthy adults.

Eligibility Criteria

Inclusion Criteria:Healthy male and female adults aged 18 - 60 yearsVitamin D deficiency as shown by serum levels of 25 (OH) D3 levels of < 20 ng/mLAble to provide informed written consentExclusion Criteria:Clinically significant abnormal laboratory parameters (such as complete blood count, CRP, d-dimer, liver enzymes, creatinine) indicative of physical illness, especially hypercalcemia and hypercalciuriaHistory of hypersensitivity to vitamin D3 supplementsHistory of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, or neurological diseasesPrior use of medications in general containing calcium, magnesium, or vitamin D3, four weeks before the start of the studyParticipation in the evaluation of any investigational product or blood donations in the last three months before this studyAny other significant disease or disorder that, in the opinion of the Physician, may either put the participant at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05706259). StuddyBuddy aggregates publicly available trial information.