Vitamin D DeficiencyNCT05706259
A Comparative Dissolution and Absorption Study of an Orodispersible Powder, Chewable Tablet and Soft Gel Capsule Vitamin D3 Supplementation
A study testing Soft gelatin 200000 IU vitamin D3 capsule and Orodispersible (sachet) 200000 IU vitamin D3 in people with Vitamin D Deficiency, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Soft gelatin 200000 IU vitamin D3 capsule and Orodispersible (sachet) 200000 IU vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Jan 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Vitamin D Bioavailability Study Following Supplementation of an Orodispersible, Chewable Tablet and Soft Gelatin Capsule Vitamin D3 Supplementation in Vitamin D Deficient Healthy Adults
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Soft gelatin 200000 IU vitamin D3 capsule, Orodispersible (sachet) 200000 IU vitamin D3
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft gelatin 200000 IU vitamin D3 capsuleDietary supplement
Weekly single dose for 3-weeks
Orodispersible (sachet) 200000 IU vitamin D3Dietary supplement
Weekly single dose for 3-weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Orodispersible (sachet) 200000 IU vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum level of 25 (OH) D
Effect on the vitamin D deficiency level
Measured: 6 weeks
Secondary outcomes (7)
Effect on liver enzymes profile
Change in serum Alanine transaminase (ALT) level
Measured: 6 weeks
Effect on liver enzymes profile
Change in serum Aspartate transaminase (AST) level
Measured: 6 weeks
Effect on liver enzymes profile
Change in serum Aspartate transaminase (AST) level
Measured: 12 weeks
Effect on liver enzymes profile
Change in serum Albumin level
Measured: 6 weeks
Effect on liver enzymes profile
Change in serum Billirubin level
Measured: 6 weeks
Effect on liver enzymes profile
Change in serum Gamma-glutamyltransferase (GGT) level
Measured: 6 weeks
Effect on kidney function
Change in serum creatinine level
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start11 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706259
- Sponsor's protocol ID
- No. LUMHS/REC/-152
- Status last verified
- May 2023
- First submitted
- 11 Jan 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37662595
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Vitamin D Bioavailability Study Following Supplementation of an Orodispersible, Chewable Tablet and Soft Gelatin Capsule Vitamin D3 Supplementation in Vitamin D Deficient Healthy Adults
- ClinicalTrials.gov ID
- NCT05706259
- Acronym / sponsor ID
- No. LUMHS/REC/-152
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft gelatin vit D supplement | Active comparator | Dietary Supplement: Soft gelatin 200000 IU vitamin D3 capsuleIn this arm subjects will receive a weekly single dose 200000 IU soft gelatin capsule of vitamin D3 for 3-weeks |
| Orodispersible vit D supplement | Experimental | Dietary Supplement: Orodispersible (sachet) 200000 IU vitamin D3In this arm subjects will receive a weekly single dose 200000 IU orodispersible (sachet) vitamin D3 for 3-weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft gelatin 200000 IU vitamin D3 capsuleWeekly single dose for 3-weeks | Dietary supplement | Soft gelatin vit D supplement |
| Orodispersible (sachet) 200000 IU vitamin D3Weekly single dose for 3-weeks | Dietary supplement | Orodispersible vit D supplement |
Primary outcome
Change in serum level of 25 (OH) D
Time frame: 6 weeks
Effect on the vitamin D deficiency level
7 secondary outcomes
Effect on liver enzymes profile
Time frame: 6 weeks
Effect on liver enzymes profile
Time frame: 6 weeks
Effect on liver enzymes profile
Time frame: 12 weeks
Effect on liver enzymes profile
Time frame: 6 weeks
Effect on liver enzymes profile
Time frame: 6 weeks
Effect on liver enzymes profile
Time frame: 6 weeks
Effect on kidney function
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 37662595Bano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft gelatin 200000 IU vitamin D3 capsule and Orodispersible (sachet) 200000 IU vitamin D3 in people with Vitamin D Deficiency, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum level of 25 (OH) D (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.