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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soft gelatin vit D supplement | Active Comparator | In this arm subjects will receive a weekly single dose 200000 IU soft gelatin capsule of vitamin D3 for 3-weeks |
|
| Orodispersible vit D supplement | Experimental | In this arm subjects will receive a weekly single dose 200000 IU orodispersible (sachet) vitamin D3 for 3-weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft gelatin 200000 IU vitamin D3 capsule | Dietary Supplement | Weekly single dose for 3-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum level of 25 (OH) D | Effect on the vitamin D deficiency level | 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaquat Medical University Hospital | Jamshoro | Sindh | 76090 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37662595 | Derived | Bano A, Abrar S, Brilli E, Tarantino G, Bugti AA, Fabbrini M, Conti G, Turroni S, Bugti M, Afridi F, Mureed S, Zada H, Din Ujjan I, Ashraf S, Ghafoor A, Khan S, Khan A. A comparative absorption study of sucrosomial(R) orodispersible vitamin D3 supplementation vs. a reference chewable tablet and soft gel capsule vitamin D3 in improving circulatory 25(OH)D levels in healthy adults with vitamin D deficiency-Results from a prospective randomized clinical trial. Front Nutr. 2023 Aug 17;10:1221685. doi: 10.3389/fnut.2023.1221685. eCollection 2023. |
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| Orodispersible (sachet) 200000 IU vitamin D3 | Dietary Supplement | Weekly single dose for 3-weeks |
|
| 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 |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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