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

• Sponsor: Liaquat University of Medical & Health Sciences (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05706259
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.1
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Dietary Supplement: Soft gelatin 200000 IU vitamin D3 capsule; Dietary Supplement: Orodispersible (sachet) 200000 IU vitamin D3	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparative Bioavailability Study of an Orodispersible vs Soft Gelatin Vitamin D3 Supplement in Vitamin D Deficient Healthy Adults
• Actual Study Start Date: Jan 11, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: May 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group B In this arm subjects will receive a weekly single dose 200000 IU soft gelatin capsule of vitamin D3 for 4-weeks	Dietary Supplement: Soft gelatin 200000 IU vitamin D3 capsule; Weekly single dose for 4-weeks
Experimental: Group A In this arm subjects will receive a weekly single dose 200000 IU orodispersible (sachet) vitamin D3 for 4-weeks	Dietary Supplement: Orodispersible (sachet) 200000 IU vitamin D3; Weekly single dose for 4-weeks

Outcome Measures

Primary Outcome Measures

1. Change in serum level of 25 (OH) D [12 weeks]

   Effect on the vitamin D deficiency level

Secondary Outcome Measures

1. Effect on liver enzymes profile [12 weeks]

   Change in serum Alanine transaminase (ALT) level

2. Effect on liver enzymes profile [12 weeks]

   Change in serum Aspartate transaminase (AST) level

3. Effect on liver enzymes profile [12 weeks]

   Change in serum Albumin level

4. Effect on liver enzymes profile [12 weeks]

   Change in serum Billirubin level

5. Effect on liver enzymes profile [12 weeks]

   Change in serum Gamma-glutamyltransferase (GGT) level

6. Effect on kidney function [12 weeks]

   Change in serum creatinine level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liaquat Medical University Hospital	Jamshoro	Sindh	Pakistan	76090

Sponsors and Collaborators

• Liaquat University of Medical & Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Amjad Khan, Professor, Liaquat University of Medical & Health Sciences
• ClinicalTrials.gov Identifier: NCT05706259
• Other Study ID Numbers: No. LUMHS/REC/-152
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vitamin D Deficiency; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins

Study Results

No Results Posted as of Jan 31, 2023