NCT05706259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

January 11, 2023

Last Update Submit

May 29, 2023

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change in serum level of 25 (OH) D

    Effect on the vitamin D deficiency level

    6 weeks

Secondary Outcomes (7)

  • Effect on liver enzymes profile

    6 weeks

  • Effect on liver enzymes profile

    6 weeks

  • Effect on liver enzymes profile

    12 weeks

  • Effect on liver enzymes profile

    6 weeks

  • Effect on liver enzymes profile

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

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

Dietary Supplement: Soft gelatin 200000 IU vitamin D3 capsule

Orodispersible vit D supplement

EXPERIMENTAL

In this arm subjects will receive a weekly single dose 200000 IU orodispersible (sachet) vitamin D3 for 3-weeks

Dietary Supplement: Orodispersible (sachet) 200000 IU vitamin D3

Interventions

Soft gelatin 200000 IU vitamin D3 capsuleDIETARY_SUPPLEMENT

Weekly single dose for 3-weeks

Soft gelatin vit D supplement
Orodispersible (sachet) 200000 IU vitamin D3DIETARY_SUPPLEMENT

Weekly single dose for 3-weeks

Orodispersible vit D supplement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat Medical University Hospital

Jamshoro, Sindh, 76090, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 37662595DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 31, 2023

Study Start

January 11, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)