Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol (PLUTO)

Scotmann

Status and phase: Unknown; Phase 2

Conditions: Vitamin D Deficiency

Treatments: Drug: Placebo SunnyD insta ampoule; Dietary Supplement: Placebo SunnyD STAT softgel capsule; Drug: SunnyD insta ampoule; Dietary Supplement: SunnyD STAT softgel capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05104970

SunnyD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

SunnyD STAT softgel capsule

Active Comparator group

Description:

Cholecalciferol 200000 IU

Treatment:

Dietary Supplement: SunnyD STAT softgel capsule

Placebo SunnyD STAT softgel capsule

Placebo Comparator group

Description:

Olive oil only

Treatment:

Dietary Supplement: Placebo SunnyD STAT softgel capsule

SunnyD insta ampoule

Active Comparator group

Description:

Vitamin D3 200000 IU

Treatment:

Drug: SunnyD insta ampoule

Placebo SunnyD insta ampoule

Placebo Comparator group

Description:

Olive oil only

Treatment:

Drug: Placebo SunnyD insta ampoule