Vitamin D DeficiencyPhase 4NCT03035084
Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?
A Phase 4 study testing Vitamin D3 and Vitamin D2 in people with Vitamin D Deficiency and 25-Hydroxyvitamin D Concentration, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, 25-Hydroxyvitamin D Concentration
- What is being tested?
- Vitamin D3 and Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Feb 2017to 20 Nov 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-pregnant adults (age ≥18 years)
- healthy
- total 25(OH)D level between 20 to 65 nmol/L.
- living in Riyadh area
Who cannot join
- consumption of more than one serving of milk daily
- taking vitamin D supplements
- habitual weekly sun exposure of 10 hours or more
- history of granulomatous, liver, or kidney disease
- taking anticonvulsants, barbiturates, or steroids
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Riyadh, Central, 11211
About this study
Official title: Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial
Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.
The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve
- Being tested
- Vitamin D3, Vitamin D2, Placebo oral capsule
- 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 D3Drug
Also called cholecalciferol
Single oral dose of 50,000 IU of vitamin D3
Vitamin D2Drug
Also called Ergocalciferol
Single oral dose of 50,000 IU of vitamin D2
Placebo oral capsuleDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Group-2-D3 | Experimental | Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3 Receives: Drug: Vitamin D3; Drug: Vitamin D2 |
| Group-2-Placebo | Placebo comparator | Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule. Receives: Drug: Vitamin D2; Drug: Placebo oral capsule |
| Group-1-D2 | Experimental | Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2. Receives: Drug: Vitamin D2 |
| Group-1-Placebo | Placebo comparator | Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
Measured: day 28
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
Measured: day 28
Secondary outcomes (5)
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
Measured: day 56
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
Measured: day 56
Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level
Measured: day 28
Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level
Measured: day 28
Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad M Hammami, MD, PhD, Principal investigator, King Faisal Specialist Hospital & Research Center (Riydah)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035084
- Sponsor's protocol ID
- RAC2161235
- Status last verified
- Aug 2018
- First submitted
- 15 Jan 2017
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hammami MM, Abuhdeeb K, Hammami S, Yusuf A. Vitamin-D2 treatment-associated decrease in 25(OH)D3 level is a reciprocal phenomenon: a randomized controlled trial. BMC Endocr Disord. 2019 Jan 18;19(1):8. doi: 10.1186/s12902-019-0337-8.
PubMed 30658603
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03035084
- Acronym / sponsor ID
- RAC2161235
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.
The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group-2-D3 | Experimental | Drug: Vitamin D3, Drug: Vitamin D2Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3 |
| Group-2-Placebo | Placebo comparator | Drug: Vitamin D2, Drug: Placebo oral capsuleSubjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule. |
| Group-1-D2 | Experimental | Drug: Vitamin D2Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2. |
| Group-1-Placebo | Placebo comparator | Drug: Placebo oral capsuleSubjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-pregnant adults (age ≥18 years)
- healthy
- total 25(OH)D level between 20 to 65 nmol/L.
- living in Riyadh area
Key exclusion criteria (5 listed)
- consumption of more than one serving of milk daily
- taking vitamin D supplements
- habitual weekly sun exposure of 10 hours or more
- history of granulomatous, liver, or kidney disease
- taking anticonvulsants, barbiturates, or steroids
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 D3Also: cholecalciferolSingle oral dose of 50,000 IU of vitamin D3 | Drug | Group-2-D3 |
| Vitamin D2Also: ErgocalciferolSingle oral dose of 50,000 IU of vitamin D2 | Drug | Group-1-D2, Group-2-D3, Group-2-Placebo |
| Placebo oral capsulePlacebo oral capsule | Drug | Group-1-Placebo, Group-2-Placebo |
Primary outcome
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
Time frame: day 28
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
Time frame: day 28
5 secondary outcomes
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
Time frame: day 56
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
Time frame: day 56
Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level
Time frame: day 28
Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level
Time frame: day 28
Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group
Time frame: day 28
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 13 Aug 2018.
- Derived from this study: PubMed 30658603Hammami MM, Abuhdeeb K, Hammami S, Yusuf A. Vitamin-D2 treatment-associated decrease in 25(OH)D3 level is a reciprocal phenomenon: a randomized controlled trial. BMC Endocr Disord. 2019 Jan 18;19(1):8. doi: 10.1186/s12902-019-0337-8.
- Individual participant dataSharing planned: Undecided
Related trials for Vitamin D Deficiency
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
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.
Muhammad M Hammami, MD, PhD principal investigator
King Faisal Specialist Hospital & Research Center (Riydah)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 and Vitamin D2 in people with Vitamin D Deficiency and 25-Hydroxyvitamin D Concentration, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 4 inclusion and 5 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 13 Aug 2018. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 (time frame: day 28). The study lists 2 primary outcomes in all. 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 NCT03035084, 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 13 Aug 2018.