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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Soft gelatin 200000 IU vitamin D3 capsule
* Dietary Supplement: Orodispersible (sachet) 200000 IU vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soft gelatin vit D supplement<br>In this arm subjects will receive a weekly single dose 200000 IU soft gelatin capsule of vitamin D3 for 3-weeks | Dietary Supplement: Soft gelatin 200000 IU vitamin D3 capsule<br>* Weekly single dose for 3-weeks<br>|
| Experimental: Orodispersible vit D supplement<br>In this arm subjects will receive a weekly single dose 200000 IU orodispersible (sachet) vitamin D3 for 3-weeks | Dietary Supplement: Orodispersible (sachet) 200000 IU vitamin D3<br>* Weekly single dose for 3-weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum level of 25 (OH) D | Effect on the vitamin D deficiency level | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on liver enzymes profile | Change in serum Alanine transaminase (ALT) level | 6 weeks | 
| Effect on liver enzymes profile | Change in serum Aspartate transaminase (AST) level | 6 weeks | 
| Effect on liver enzymes profile | Change in serum Aspartate transaminase (AST) level | 12 weeks | 
| Effect on liver enzymes profile | Change in serum Albumin level | 6 weeks | 
| Effect on liver enzymes profile | Change in serum Billirubin level | 6 weeks | 
| Effect on liver enzymes profile | Change in serum Gamma-glutamyltransferase (GGT) level | 6 weeks | 
| Effect on kidney function | Change in serum creatinine level | 6 weeks |