Clinical trial NCT05706259: A Comparative Dissolution and Absorption Study of an Orodispersible Powder, Chewable Tablet and Soft Gel Capsule Vitamin D3 Supplementation
Official title: A Comparative Vitamin D Bioavailability Study Following Supplementation of an Orodispersible, Chewable Tablet and Soft Gelatin Capsule Vitamin D3 Supplementation in Vitamin D Deficient Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Vitamin D is a fat-soluble vitamin used by the body for normal bone development and maintenance by increasing the absorption of calcium, magnesium, and phosphate. Vitamin D also plays a role in the nervous system, musculoskeletal system and immune system. Vitamin D deficiency has been linked with diverse health conditions including diabetes, cardiovascular diseases, breast, colorectal and prostate cancer, dementia, depression, erectile dysfunction, osteoporosis, and bone disorders. Vitamin D deficiency is a global healthcare challenge. To overcome vitamin D deficiency, a daily vitamin D supplementation of 200-1000 IU or a high dosage from 25000 to 200000 IU for 4-6 weeks, is normally recommended.

Vitamin D supplements are available over the counter in different delivery vehicles (formulations) to reach the circulatory system. In the present study the investigators aim to evaluate the pharmacokinetics of an orodispersible vitamin D supplement vs a conventional oral soft gelatin capsule, in vitamin D deficient healthy adults to assess how different vitamin D supplement formulations can efficiently overcome the vitamin D deficiency.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults aged 18 - 60 years
* Vitamin D deficiency as shown by serum levels of 25 (OH) D3 levels of \< 20 ng/mL
* Able to provide informed written consent

Exclusion Criteria:

* Clinically significant abnormal laboratory parameters (such as complete blood count, CRP, d-dimer, liver enzymes, creatinine) indicative of physical illness, especially hypercalcemia and hypercalciuria
* History of hypersensitivity to vitamin D3 supplements
* History of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, or neurological diseases
* Prior use of medications in general containing calcium, magnesium, or vitamin D3, four weeks before the start of the study
* Participation in the evaluation of any investigational product or blood donations in the last three months before this study
* Any 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

Primary outcomes:
measure: Change in serum level of 25 (OH) D
timeFrame: 6 weeks
Secondary outcomes:
measure: Effect on liver enzymes profile
timeFrame: 6 weeks
measure: Effect on liver enzymes profile
timeFrame: 6 weeks
measure: Effect on liver enzymes profile
timeFrame: 12 weeks
measure: Effect on liver enzymes profile
timeFrame: 6 weeks
measure: Effect on liver enzymes profile
timeFrame: 6 weeks
measure: Effect on liver enzymes profile
timeFrame: 6 weeks
measure: Effect on kidney function
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jamshoro
country: Pakistan
facility: Liaquat Medical University Hospital
state: Sindh
Study officials:
References: