Vitamin D Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSoft gelatin 200000 IU vitamin D3 capsule
Weekly single dose for 3-weeks
DIETARY_SUPPLEMENTOrodispersible (sachet) 200000 IU vitamin D3
Weekly single dose for 3-weeks
Sponsors
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum level of 25 (OH) D | 6 weeks | Effect on the vitamin D deficiency level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on liver enzymes profile | 6 weeks | Change in serum Alanine transaminase (ALT) level |
| Effect on kidney function | 6 weeks | Change in serum creatinine level |
Countries
Pakistan
Outcome results
None listed