A Comparative Dissolution and Absorption Study of an Orodispersible Powder, Chewable Tablet and Soft Gel Capsule Vitamin D3 Supplementation

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706259
• Other study ID #: No. LUMHS/REC/-152
• Status: Completed
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Soft gelatin 200000 IU vitamin D3 capsule
Weekly single dose for 3-weeks
• Orodispersible (sachet) 200000 IU vitamin D3
Weekly single dose for 3-weeks

Locations

Country	Name	City	State
Pakistan	Liaquat Medical University Hospital	Jamshoro	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum level of 25 (OH) D	Effect on the vitamin D deficiency level	6 weeks
Secondary	Effect on liver enzymes profile	Change in serum Alanine transaminase (ALT) level	6 weeks
Secondary	Effect on liver enzymes profile	Change in serum Aspartate transaminase (AST) level	6 weeks
Secondary	Effect on liver enzymes profile	Change in serum Aspartate transaminase (AST) level	12 weeks
Secondary	Effect on liver enzymes profile	Change in serum Albumin level	6 weeks
Secondary	Effect on liver enzymes profile	Change in serum Billirubin level	6 weeks
Secondary	Effect on liver enzymes profile	Change in serum Gamma-glutamyltransferase (GGT) level	6 weeks
Secondary	Effect on kidney function	Change in serum creatinine level	6 weeks