Vitamin D DeficiencyNCT06618365

Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency

A study testing Vitamin D Deficiency in people with Vitamin D Deficiency, run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Vitamin D Deficiency
What is being tested?: Vitamin D Deficiency
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteQatar
Study dates: 2 Feb 2023to Dec 2025
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 20 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 20-50 years
Basal Vit D level should be between 10-18 ng/ml for phase 1 and between 30-50 ng/ml for phase 2

Who cannot join

Pregnant Women
history of renal implant or renal impairment of eGFR less than 60%
Abnormal Liver function test
patients with inflammatory bowel disease or of history of bariatric surgery

Trial locations and contacts

1 site in 1 country.

Qatar1 site

Hamad Medical Corporation
Doha, 3050

Other trials in Qatar

About this study

Official title: Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency.

The main purpose of this research is to find out if there is any difference between treating vitamin D deficiency with oral vitamin D3 or I.M vitamin D2. The second aim of this research is to confirm the superiority of Vitamin D3 over Vitamin D2 in treating vitamin D deficiency. Additional useful information in this research is to find out the best recommended maintenance dose of vitamin D and formula by having regular follow up of treated individuals once their serum vitamin D level reach the recommended normal serum level.

Read the detailed description

In a systemic review, it was found that treating individuals who have vitamin D deficiency with vitamin D3 rather than vitamin D2 would be a better option. Vitamin D3 is superior in treating Vitamin D deficiency according to this systemic review. However, this systemic review raised a question of comparing oral to I.M treatment of vitamin D deficiency and no Data was available to support either treatment above the other.

The research will involve 100 patients between the age of 20-50 years old. They will be divided into 4 groups. Each group will have either oral or I.M vitamin D2 or oral or I.M vitamin D3. The oral doses will be 50000 international units to be taken weekly and the I.M doses will be of 300000 international units which will be taken once every 6 weeks. Vitamin D level will be checked once every 4 weeks. The initial expected duration of the first phase of the research will be about 6-12 weeks which will give us a good orientation to answer the main and the second questions. Then the follow up may take up to another 6 months to check the maintenance dose of the best recommended oral or I.M treatment of bolus doses in certain intervals as initial trial.

Conditions: Vitamin D Deficiency
Being tested: Vitamin D Deficiency
Keywords: Vitamin D, Endocrinology
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.

Vitamin D DeficiencyDrug
The first phase will involve studying 4 groups with the outcome (percentage of patients attaining Vitamin D levels \>30ng/ml) at 3 months to show the superiority of any of the groups. Vitamin D levels will be checked at baseline then 6 and 12 weeks. The second phase will include only patients who achieve the target level above 30ng/ml after the first phase and will be randomized to receive either oral Vitamin D2 or oral Vitamin D3 every 2, 3 or 4 weeks for another 3 months.
For patients that achieved normal level in phase 1, we will keep a maintenance dose of the oral Vitamin D for 2 groups with 3 sub-groups under each.

Study groups in NCT06618365
Study group	Role	What they receive
Group 1: Vitamin D2 50000 units per tablet	Experimental	They will take one tablet weekly. Receives: Drug: Vitamin D Deficiency
Group 2: Vitamin D2 300000 units Intramuscular injection	Experimental	They will have one injection every 6 weeks initially. Receives: Drug: Vitamin D Deficiency
Group 3: Vitamin D3 50000 units tablet	Experimental	They will take one tablet weekly. Receives: Drug: Vitamin D Deficiency
Group 4: Vitamin D3 300000 units Intramuscular injection	Experimental	They will have one injection every 6 weeks initially. Receives: Drug: Vitamin D Deficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

Is oral Vitamin D3 superior to I.M Vitamin D2 in treating vitamin D deficiency?
The primary outcome will be evaluated after 3 months from administration of the first dose for each subject to assess the serum level of vitamin D is attained. If a subject has reached normal Vitamin D serum level, they are qualified for phase 2 of the study.
Measured: 3 months from the administration of first dose

Secondary outcomes (2)

Confirming superiority of oral Vitamin D3 over oral Vitamin D2
The secondary outcome of confirming the superiority of oral Vitamin D3 over oral Vitamin D2 in treating vitamin D deficiency will be evaluated after a subject has completed 3 months since the administration of the first dose.
Measured: 3 months after administration of the first dose.
to compare the treatment of vitamin D deficiency by using intramuscular injection of vitamin D3 or Vitamin D2
The third outcome also to compare the treatment of vitamin D deficiency by using intramuscular injection of vitamin D3 or Vitamin D2 and establish if there is any treatment is superior to another if we are using the intramuscular injections.
Measured: 3 months after administration of the first dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 2023Dec 2025

First posted1 Oct 2024
Study start2 Feb 2023
Primary completionJul 2025 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
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
Model description: prospective randomized intervention using open label randomization.
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06618365
Sponsor's protocol ID: MRC-01-18-036
Status last verified: Sep 2024
First submitted: 8 Sep 2024
Last updated: 1 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: This was not intended initially, and the consent form does not include any clause for the participants to request sharing their data with other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vitamin D Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency.
ClinicalTrials.gov ID: NCT06618365
Acronym / sponsor ID: MRC-01-18-036
Conditions: Vitamin D Deficiency
Keywords: Vitamin D, Endocrinology
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Hamad Medical CorporationIndustry (pharma, biotech, devices)
Study start: 2 Feb 2023 (actual)
Primary completion: Jul 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 1 Oct 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: prospective randomized intervention using open label randomization.

Arm	Type	Receives
Group 1: Vitamin D2 50000 units per tablet	Experimental	Drug: Vitamin D DeficiencyThey will take one tablet weekly.
Group 2: Vitamin D2 300000 units Intramuscular injection	Experimental	Drug: Vitamin D DeficiencyThey will have one injection every 6 weeks initially.
Group 3: Vitamin D3 50000 units tablet	Experimental	Drug: Vitamin D DeficiencyThey will take one tablet weekly.
Group 4: Vitamin D3 300000 units Intramuscular injection	Experimental	Drug: Vitamin D DeficiencyThey will have one injection every 6 weeks initially.

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Age 20-50 years
Basal Vit D level should be between 10-18 ng/ml for phase 1 and between 30-50 ng/ml for phase 2

Key exclusion criteria (4 listed)

Pregnant Women
history of renal implant or renal impairment of eGFR less than 60%
Abnormal Liver function test
patients with inflammatory bowel disease or of history of bariatric surgery

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
Vitamin D DeficiencyThe first phase will involve studying 4 groups with the outcome (percentage of patients attaining Vitamin D levels \>30ng/ml) at 3 months to show the superiority of any of the groups. Vitamin D levels will be checked at baseline then 6 and 12 weeks. The second phase will include only patients who achieve the target level above 30ng/ml after the first phase and will be randomized to receive either oral Vitamin D2 or oral Vitamin D3 every 2, 3 or 4 weeks for another 3 months. For patients that achieved normal level in phase 1, we will keep a maintenance dose of the oral Vitamin D for 2 groups with 3 sub-groups under each.	Drug	Group 1: Vitamin D2 50000 units per tablet, Group 2: Vitamin D2 300000 units Intramuscular injection, Group 3: Vitamin D3 50000 units tablet, Group 4: Vitamin D3 300000 units Intramuscular injection

Primary outcome

Is oral Vitamin D3 superior to I.M Vitamin D2 in treating vitamin D deficiency?
Time frame: 3 months from the administration of first dose
The primary outcome will be evaluated after 3 months from administration of the first dose for each subject to assess the serum level of vitamin D is attained. If a subject has reached normal Vitamin D serum level, they are qualified for phase 2 of the study.

2 secondary outcomes

Confirming superiority of oral Vitamin D3 over oral Vitamin D2
Time frame: 3 months after administration of the first dose.
to compare the treatment of vitamin D deficiency by using intramuscular injection of vitamin D3 or Vitamin D2
Time frame: 3 months after administration of the first dose.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Individual participant dataSharing planned: No. This was not intended initially, and the consent form does not include any clause for the participants to request sharing their data with other researchers.

Related trials for Vitamin D Deficiency

RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia

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 Vitamin D Deficiency in people with Vitamin D Deficiency, run by Hamad Medical Corporation at 1 site in Qatar.

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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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 Qatar. 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?

Results are not available in the source record.

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?

Is oral Vitamin D3 superior to I.M Vitamin D2 in treating vitamin D deficiency? (time frame: 3 months from the administration of first dose). 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 NCT06618365.

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 1 Oct 2024.