Vitamin D Deficiency
Conditions
Keywords
Vitamin D
Brief summary
The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.
Detailed description
Deficiency of Vitamin D is highly prevalent in all sectors and regions of Pakistan. Its effects encompass multiple pluripotent physiological impacts on human body, including its classical action on bone health and immune modulation. Health care workers are routinely prescribing supplementations to correct the deficiencies. Different forms of Cholecalciferol are available in the market. It ranges from absorba liquids, drops, tablets, softgels to injectable and oral ampoules. Different delivery systems offer different advantages, challenges and efficacies specific to their specific pharmacokinetics. The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.
Interventions
DRUGSunnyD insta ampoule
Cholecalciferol 200000 IU insta ampoule
DIETARY_SUPPLEMENTSunnyD STAT softgel capsule
Cholecalciferol 200000 IU softgel capsule
DRUGPlacebo SunnyD insta ampoule
Olive oil
DIETARY_SUPPLEMENTPlacebo SunnyD STAT softgel capsule
Olive oil
Sponsors
Rawalpindi Medical College
Scotmann Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
double blinded placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult (20-70 years of age) 2. Vitamin D deficiency (serum 25(OH)D \< 20 ng/ml) 3. Permanent employees of Medicine ward of Holy Family Hospital, DHQ, BBH hospitals and RMU for easy follow up throughout the study duration 4. Willingness and availability to show-up in the follow up visit and serum testing throughout the study period as needed
Exclusion criteria
1. Vitamin D sufficiency or moderate deficiency (serum 25(OH)D \> 20 ng/ml) 2. Pregnant ladies 3. Participants already taking Vitamin D supplementation, anti-convulsants, barbiturates or steroids 4. Subjects with granulomatous conditions, liver disease, kidney disease, or diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under Curve (AUC) | 70 days | Area Under Curve (AUC) trail follow-up at 0,1,7,28,70. Trapezoidal method for calculations would be used and levels would be reported from lab essay of 25(OH)D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum 25(OH)D level | 3 months | Serum 25(OH)D level would be checked at the end of the trial after 3 months to assess the change in levels (if any). It would be assessed through laboratory essay |
Contacts
Primary ContactSyeda Saba Aslam, MBBS, MPH
Backup ContactFazlur Rehman, MBBS,FCPS
Outcome results
None listed