Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-02-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

double blinded placebo controlled

Study Groups

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SunnyD STAT softgel capsule

Cholecalciferol 200000 IU

Group Type ACTIVE_COMPARATOR

SunnyD STAT softgel capsule

Intervention Type DIETARY_SUPPLEMENT

Cholecalciferol 200000 IU softgel capsule

Placebo SunnyD STAT softgel capsule

Olive oil only

Group Type PLACEBO_COMPARATOR

Placebo SunnyD STAT softgel capsule

Intervention Type DIETARY_SUPPLEMENT

Olive oil

SunnyD insta ampoule

Vitamin D3 200000 IU

Group Type ACTIVE_COMPARATOR

SunnyD insta ampoule

Intervention Type DRUG

Cholecalciferol 200000 IU insta ampoule

Placebo SunnyD insta ampoule

Olive oil only

Group Type PLACEBO_COMPARATOR

Placebo SunnyD insta ampoule

Intervention Type DRUG

Olive oil

Interventions

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SunnyD insta ampoule

Cholecalciferol 200000 IU insta ampoule

Intervention Type DRUG

SunnyD STAT softgel capsule

Cholecalciferol 200000 IU softgel capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo SunnyD insta ampoule

Olive oil

Intervention Type DRUG

Placebo SunnyD STAT softgel capsule

Olive oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes