Vitamin D DeficiencyNCT01170494
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
A study testing ergocalciferol 2000 IU orally, daily, ergocalciferol 25000 IU oraly every 2 weeks and ergocalciferol 50000 IU orally every 4 weeks 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. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. 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?
- ergocalciferol 2000 IU orally, daily, ergocalciferol 25000 IU oraly every 2 weeks and ergocalciferol 50000 IU orally every 4 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2013to Apr 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy 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.
- 25 OH vitamin D level between 20 to 50 nmol/L.
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: Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial
Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.
The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.
- Conditions
- Vitamin D Deficiency
- Being tested
- ergocalciferol 2000 IU orally, daily, ergocalciferol 25000 IU oraly every 2 weeks, ergocalciferol 50000 IU orally every 4 weeks, ergocal1000 IU & cholecal 1000 IU orally daily, cholecalciferol 2000 IU orally daily
- Keywords
- vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh 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.
ergocalciferol 2000 IU orally, dailyDrug
Also called ergocalciferol
ergocalciferol 2000 IU orally, daily
ergocalciferol 25000 IU oraly every 2 weeksDrug
Also called ergocalciferol
ergocalciferol 25000 IU oraly every 2 weeks
ergocalciferol 50000 IU orally every 4 weeksDrug
Also called ergocalciferol
ergocalciferol 50000 IU orally every 4 weeks
ergocal1000 IU & cholecal 1000 IU orally dailyDrug
Also called ergocalciferol and cholecalciferol
ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day
cholecalciferol 2000 IU orally dailyDrug
Also called cholecalciferol
cholecalciferol 2000 IU orally everyday
Cholecalciferol 25000 IU orally every 2 weeksDrug
Also called Cholecalciferol
Cholecalciferol 25000 IU orally every 2 weeks
Cholecalciferol 50000 orally every 4 weeksDrug
Also called Cholecalciferol
Cholecalciferol 50000 orally every 4 weeks
placebo orally everydayDrug
Also called placebo
placebo orally everyday
| Study group | Role | What they receive |
|---|---|---|
| D2 2000 IU daily | Active comparator | Not described Receives: Drug: ergocalciferol 2000 IU orally, daily |
| D3 2000 IU daily | Active comparator | Not described Receives: Drug: cholecalciferol 2000 IU orally daily |
| D2 1000 IU + D3 1000 IU daily | Active comparator | Not described Receives: Drug: ergocal1000 IU & cholecal 1000 IU orally daily |
| D2 25000 IU Q2wk | Active comparator | Not described Receives: Drug: ergocalciferol 25000 IU oraly every 2 weeks |
| D3 25000 IU Q2wk | Active comparator | Not described Receives: Drug: Cholecalciferol 25000 IU orally every 2 weeks |
| D2 50000 IU Q4wk | Active comparator | Not described Receives: Drug: ergocalciferol 50000 IU orally every 4 weeks |
| D3 50000 IU Q4wk | Active comparator | Not described Receives: Drug: Cholecalciferol 50000 orally every 4 weeks |
| placebo daily | Placebo comparator | Not described Receives: Drug: placebo orally everyday |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve of 25 OH vitamin D level
area under the curve of total 25 OH vitamin D level from day 1 to 140
Measured: 140 days
Secondary outcomes (5)
Cmax of 25 OH vitamin D
Cmax of total 25 OH vitamin D over the treatment period of 140 days
Measured: 140 days
Tmax of 25 OH vitamin D level
Tmax of total 25 OH vitamin D over the treatment period of 140 days
Measured: 140 days
area under the curve of vitamin D level
area under the curve of total vitamin D level over 140 days
Measured: 140 days
incidence of hypercalcemia
Measured: 140 days
incidence of hypercalciuria
Measured: 140 days
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 startFeb 2013
- Primary completionApr 2016
- Study completionApr 2016
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 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
- NCT01170494
- Sponsor's protocol ID
- RAC 2101041
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2010
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hammami MM, Yusuf A. Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. BMC Endocr Disord. 2017 Feb 24;17(1):12. doi: 10.1186/s12902-017-0163-9.
PubMed 28231782
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01170494
- Acronym / sponsor ID
- RAC 2101041
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 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. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.
The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| D2 2000 IU daily | Active comparator | Drug: ergocalciferol 2000 IU orally, daily |
| D3 2000 IU daily | Active comparator | Drug: cholecalciferol 2000 IU orally daily |
| D2 1000 IU + D3 1000 IU daily | Active comparator | Drug: ergocal1000 IU & cholecal 1000 IU orally daily |
| D2 25000 IU Q2wk | Active comparator | Drug: ergocalciferol 25000 IU oraly every 2 weeks |
| D3 25000 IU Q2wk | Active comparator | Drug: Cholecalciferol 25000 IU orally every 2 weeks |
| D2 50000 IU Q4wk | Active comparator | Drug: ergocalciferol 50000 IU orally every 4 weeks |
| D3 50000 IU Q4wk | Active comparator | Drug: Cholecalciferol 50000 orally every 4 weeks |
| placebo daily | Placebo comparator | Drug: placebo orally everyday |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy 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.
- 25 OH vitamin D level between 20 to 50 nmol/L.
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 |
|---|---|---|
| ergocalciferol 2000 IU orally, dailyAlso: ergocalciferolergocalciferol 2000 IU orally, daily | Drug | D2 2000 IU daily |
| ergocalciferol 25000 IU oraly every 2 weeksAlso: ergocalciferolergocalciferol 25000 IU oraly every 2 weeks | Drug | D2 25000 IU Q2wk |
| ergocalciferol 50000 IU orally every 4 weeksAlso: ergocalciferolergocalciferol 50000 IU orally every 4 weeks | Drug | D2 50000 IU Q4wk |
| ergocal1000 IU & cholecal 1000 IU orally dailyAlso: ergocalciferol and cholecalciferolergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day | Drug | D2 1000 IU + D3 1000 IU daily |
| cholecalciferol 2000 IU orally dailyAlso: cholecalciferolcholecalciferol 2000 IU orally everyday | Drug | D3 2000 IU daily |
| Cholecalciferol 25000 IU orally every 2 weeksAlso: CholecalciferolCholecalciferol 25000 IU orally every 2 weeks | Drug | D3 25000 IU Q2wk |
| Cholecalciferol 50000 orally every 4 weeksAlso: CholecalciferolCholecalciferol 50000 orally every 4 weeks | Drug | D3 50000 IU Q4wk |
| placebo orally everydayAlso: placeboplacebo orally everyday | Drug | placebo daily |
Primary outcome
area under the curve of 25 OH vitamin D level
Time frame: 140 days
area under the curve of total 25 OH vitamin D level from day 1 to 140
5 secondary outcomes
Cmax of 25 OH vitamin D
Time frame: 140 days
Tmax of 25 OH vitamin D level
Time frame: 140 days
area under the curve of vitamin D level
Time frame: 140 days
incidence of hypercalcemia
Time frame: 140 days
incidence of hypercalciuria
Time frame: 140 days
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 Aug 2016.
- Derived from this study: PubMed 28231782Hammami MM, Yusuf A. Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. BMC Endocr Disord. 2017 Feb 24;17(1):12. doi: 10.1186/s12902-017-0163-9.
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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 study testing ergocalciferol 2000 IU orally, daily, ergocalciferol 25000 IU oraly every 2 weeks and ergocalciferol 50000 IU orally every 4 weeks 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: finished, as of the sponsor's last update on 31 Aug 2016. 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.
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?
area under the curve of 25 OH vitamin D level (time frame: 140 days). 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 NCT01170494, 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 Aug 2016.