Vitamin D DeficiencyPhase 1/2NCT01170507
Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation
A Phase 1/2 study testing vitamin D3 1000 IU orally daily for 5 months, vitamin D3 3000 IU orally daily for 5 months and vitamin D3 5000 IU orally daily for 5 months in people with Vitamin D Deficiency, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D3 1000 IU orally daily for 5 months, vitamin D3 3000 IU orally daily for 5 months and vitamin D3 5000 IU orally daily for 5 months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2011to Aug 2016
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
- Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
About this study
Official title: Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study
Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.
The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D3 1000 IU orally daily for 5 months, vitamin D3 3000 IU orally daily for 5 months, vitamin D3 5000 IU orally daily for 5 months, Placebo orally daily for 5 months
- Keywords
- vitamin D3, 25 OH vitamin D3 level
- 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 D3 1000 IU orally daily for 5 monthsDrug
vitamin D3 3000 IU orally daily for 5 monthsDrug
vitamin D3 5000 IU orally daily for 5 monthsDrug
Placebo orally daily for 5 monthsDrug
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 1000 IU | Active comparator | Not described Receives: Drug: vitamin D3 1000 IU orally daily for 5 months |
| Vitamin D3 3000 IU | Active comparator | Not described Receives: Drug: vitamin D3 3000 IU orally daily for 5 months |
| Vitamin D3 5000 IU | Active comparator | Not described Receives: Drug: vitamin D3 5000 IU orally daily for 5 months |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo orally daily for 5 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of 25 OH vitamin D3 level vs vitamin D3 dose
The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months.
Measured: 5 months
Secondary outcomes (4)
slope of vitamin D3 level vs vitamin D3 dose
slope of vitamin D3 level vs vitamin D3 dose over 5 months
Measured: 5 months
incidence of hypercalcemia
incidence of hypercalcemia over 8 months
Measured: 8 months
incidence of hypercalciuria
incidence of hypercalciuria over 8 months
Measured: 8 months
slope of decline of 25 OH vitamin D3 level vs time
slope of decline of 25 OH vitamin D3 level vs time over 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startDec 2011
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: No funding
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
- Investigators
- Muhammad M Hammami, MD, PhD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170507
- Sponsor's protocol ID
- RAC 2101042
- Status last verified
- Mar 2018
- First submitted
- 25 Jul 2010
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01170507
- Acronym / sponsor ID
- RAC 2101042
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D3, 25 OH vitamin D3 level
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Jul 2010 (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.
Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.
The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 1000 IU | Active comparator | Drug: vitamin D3 1000 IU orally daily for 5 months |
| Vitamin D3 3000 IU | Active comparator | Drug: vitamin D3 3000 IU orally daily for 5 months |
| Vitamin D3 5000 IU | Active comparator | Drug: vitamin D3 5000 IU orally daily for 5 months |
| Placebo | Placebo comparator | Drug: Placebo orally daily for 5 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
- Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.
Key exclusion criteria (0 listed)
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 D3 1000 IU orally daily for 5 months | Drug | vitamin D3 1000 IU |
| vitamin D3 3000 IU orally daily for 5 months | Drug | Vitamin D3 3000 IU |
| vitamin D3 5000 IU orally daily for 5 months | Drug | Vitamin D3 5000 IU |
| Placebo orally daily for 5 months | Drug | Placebo |
Primary outcome
Slope of 25 OH vitamin D3 level vs vitamin D3 dose
Time frame: 5 months
The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months.
4 secondary outcomes
slope of vitamin D3 level vs vitamin D3 dose
Time frame: 5 months
incidence of hypercalcemia
Time frame: 8 months
incidence of hypercalciuria
Time frame: 8 months
slope of decline of 25 OH vitamin D3 level vs time
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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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.
Muhammad M Hammami, MD, PhD principal investigator
King Faisal Specialist Hospital & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing vitamin D3 1000 IU orally daily for 5 months, vitamin D3 3000 IU orally daily for 5 months and vitamin D3 5000 IU orally daily for 5 months in people with Vitamin D Deficiency, 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 2 inclusion and 0 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: withdrawn, as of the sponsor's last update on 7 Mar 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Slope of 25 OH vitamin D3 level vs vitamin D3 dose (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2018.