Vitamin D2 Supplementation in Vitamin D InsufficiencyPhase 4NCT03228862
Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults
A Phase 4 study testing Ergocalciferol in people with Vitamin D2 Supplementation in Vitamin D Insufficiency, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vitamin D2 Supplementation in Vitamin D Insufficiency
- What is being tested?
- Ergocalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2017to 1 Feb 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult age ≥ 15 years
- BMI 18 - 35 kg/m2
- Serum 25(OH)D < 30ng/ml
Who cannot join
- Hypercalcemia, nephrolithiasis, or fractures
- Hepatic disease
- Kidney disease
- Granulomatous disease
- Currently supplemented with vitamin D
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital
Bangkok, 13310
About this study
Official title: Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study
To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults.
Read the detailed description
A double-blinded prospective, randomized study undertaken at outpatient clinic of King Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and divided into three groups according to their initial 25OHD concentrations. Patients are randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD concentration are measure again at the end of the study.
- Being tested
- Ergocalciferol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Ergocalciferol 40000, 60000 and 80000 once weekly
| Study group | Role | What they receive |
|---|---|---|
| D40000 | Experimental | Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly Receives: Drug: Ergocalciferol |
| D60000 | Experimental | Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly Receives: Drug: Ergocalciferol |
| D80000 | Experimental | Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly Receives: Drug: Ergocalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25OHD phase 1
serum 25OHD concentration after initial vitamin D2 supplemetaiton
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 May 2017
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D2 Supplementation in Vitamin D InsufficiencyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lalita Wattanachanya, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228862
- Sponsor's protocol ID
- 088/60
- Status last verified
- Jul 2017
- First submitted
- 21 Jul 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study
- ClinicalTrials.gov ID
- NCT03228862
- Acronym / sponsor ID
- 088/60
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 25 Jul 2017 (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.
To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults.
Detailed description
A double-blinded prospective, randomized study undertaken at outpatient clinic of King Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and divided into three groups according to their initial 25OHD concentrations. Patients are randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD concentration are measure again at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D40000 | Experimental | Drug: ErgocalciferolPatients are randomly assigned to receive Ergocalciferol 40000 IU once weekly |
| D60000 | Experimental | Drug: ErgocalciferolPatients are randomly assigned to receive Ergocalciferol 60000 IU once weekly |
| D80000 | Experimental | Drug: ErgocalciferolPatients are randomly assigned to receive Ergocalciferol 80000 IU once weekly |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age ≥ 15 years
- BMI 18 - 35 kg/m2
- Serum 25(OH)D < 30ng/ml
Key exclusion criteria (5 listed)
- Hypercalcemia, nephrolithiasis, or fractures
- Hepatic disease
- Kidney disease
- Granulomatous disease
- Currently supplemented with vitamin D
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 |
|---|---|---|
| ErgocalciferolErgocalciferol 40000, 60000 and 80000 once weekly | Drug | D40000, D60000, D80000 |
Primary outcome
serum 25OHD phase 1
Time frame: 12 weeks
serum 25OHD concentration after initial vitamin D2 supplemetaiton
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
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 Phase 4 study testing Ergocalciferol in people with Vitamin D2 Supplementation in Vitamin D Insufficiency, run by Chulalongkorn University at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 26 Jul 2017. 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 Thailand. 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.
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?
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?
serum 25OHD phase 1 (time frame: 12 weeks). 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 26 Jul 2017.