Vitamin D DeficiencyNCT02553044
Change in Free 25(OH)D After High Dose in Vitamin D Deficient Postmenopausal Women
A study testing Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency and Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Total 25(OH)D is currently used as a biomarker of vitamin D status. However, there is some debate as to whether total 25(OH)D is the best marker to use. It has been suggested that free vitamin D may be better because it may be more biologically available. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Osteoporosis
- What is being tested?
- Cholecalciferol (Vitamin D3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Aug 2018
- 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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian
- 25(OH)D < 30nmol/l for treatment groups or 25(OH)D >50nmol/l for control group
- BMI between 20 kg/m2 and 30kg/m2
- 55 years and over and postmenopausal (at least 5 years since last menstrual period)
- Able and willing to participate in the study and provide written informed consent.
Who cannot join
- History of any long term immobilization (duration greater than three months)
- Pre-diagnosed diabetes mellitus
- High trauma fracture or low trauma fracture less than one year prior to recruitment
- History of or current conditions known to affect vitamin D or bone metabolism, including:
- Chronic renal disease Malabsorption syndromes Diagnosed endocrine disorders Hypercalcaemia Diagnosed restrictive eating disorder
- Use of medications or treatment known to affect vitamin D or bone metabolism such as bisphosphonates or anti-epileptic medication.
Show all 10Show fewer
- Alcohol intake of greater than 21 units per week
- Holiday with significant sunlight exposure in the last six weeks
- Planned sun holiday within study period
- Abnormal clinical laboratory parameters that are assessed as clinically significant by the PI.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility
Sheffield, South Yorkshire, S5 7AU
About this study
Total 25(OH)D is currently used as a biomarker of vitamin D status. However, there is some debate as to whether total 25(OH)D is the best marker to use.
It has been suggested that free vitamin D may be better because it may be more biologically available.
Read more
There are also some uncertainties about how we treat vitamin D deficiency. A single dose is attractive because it is certain that the patient has had the dose and there is no requirement for ongoing compliance, but it is still not clear what the best dose is to give. Also, recent studies have highlighted that high dose vitamin D supplementation may increase the risk of falling in older populations.
The investigators believe that studying how free vitamin D responds to different bolus doses is the best way address some of the current research gaps, including what is the best biomarker of vitamin D status, what is the mechanism of vitamin D toxicity and what is a safe bolus dose to treat deficiency.
The investigators will study changes in total and free 25(OH)D, and also clinical response, to three different bolus doses of vitamin D (50 000IU, 150 000IU and 500 000IU) in 84 vitamin D deficient postmenopausal women, over a three month period with 5 study visits. A concurrent control group of 28 vitamin D sufficient postmenopausal women will also be recruited.
This will allow the investigators to determine how total and free vitamin D change with bolus dosing and whether there is a disproportionate rise in free 25(OH)D with higher doses that may lead to hypercalcemia and falls.
Read the detailed description
The most commonly used measurement of vitamin D status is serum 25-hydroxyvitamin D (25(OH)D). However there is no clear consensus on the level of 25(OH)D required to protect against adverse effects of deficiency.
One approach is to define deficiency is the level of 25(OH)D at which there is a secondary physiological response, such as a rise in parathyroid hormone. However, this approach has not yielded a clear answer. Total 25(OH)D below 30nmol/l is not always associated with an increased parathyroid hormone (PTH) response, and total 25(OH)D and PTH do not always respond to vitamin D supplementation. This suggests that total 25(OH)D measurement may not be the best biological marker of vitamin D status.
Vitamin D and its metabolites are bound to proteins in the circulation: around 85-90% of 25(OH)D is bound to vitamin D binding protein (DBP), 10-15% is bound to albumin, and less than 1% is in the free form. DBP protects 25(OH)D from degradation and allows a circulating store to accumulate.
The free hormone hypothesis suggests that only the unbound 'free' portion of protein bound hormones is biologically active, and that this should be measured for the accurate assessment of hormone availability. Calculated free 25(OH)D concentrations have been shown to be better correlated to bone mineral density (BMD) than total 25(OH)D in a healthy population and to be more closely related to PTH in patients with end stage renal disease.
The binding capacity of DBP may be overwhelmed in some situations. In female participants treated with an oral dose of 500,000 IU annually for 3 years there was an increase in the risk of falls and fractures that was particularly marked in the three month period after each dose. It has been proposed that there was vitamin D toxicity and possible hypercalcaemia during this period due to the binding capacity of DBP being overwhelmed by the large increase in 25(OH)D with a relatively greater increase in free 25(OH)D. However, free vitamin D and calcium were not measured in the study, so there is not yet evidence to support this hypothesis.
The investigators will study changes in total and free 25(OH)D, and clinical response to three different bolus doses of vitamin D (50,000 units, 150,000 units and 500,000 units) in 84 vitamin D deficient (<30nmol/l) postmenopausal women over three months. This will allow the investigators to determine how free and total 25(OH)D change with bolus dosing and whether there is a disproportionately high rise in free 25(OH)D with higher doses. This will also generate a better understanding of what the optimum bolus dose for treatment of vitamin D deficiency is and whether free 25(OH)D may be a better marker of vitamin D status in some situations.
Aims of the study:
- To determine the effect of three different vitamin D bolus doses on free 25(OH)D and total 25(OH)D in vitamin D deficient post-menopausal women.
- To determine the effect of different vitamin D bolus doses on parameters of calcium metabolism, bone turnover markers and physical function in vitamin D deficient post-menopausal women.
- Conditions
- Vitamin D Deficiency, Osteoporosis
- Being tested
- Cholecalciferol (Vitamin D3)
- Medical subject headings
- Vitamin D Deficiency, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (Vitamin D3)Dietary supplement
Also called Invita D3
Oral vitamin D3 doses made up using 50 000IU ampules of vitamin D3 dissolved in 1ml of olive oil.
| Study group | Role | What they receive |
|---|---|---|
| 50 000IU Vitamin D3 | Experimental | 50 000IU oral vitamin D3 (cholecalciferol) administered at baseline only. Receives: Dietary Supplement: Cholecalciferol (Vitamin D3) |
| 150 000IU Vitamin D3 | Experimental | 150 000IU oral vitamin D3 (cholecalciferol) administered at baseline only. Receives: Dietary Supplement: Cholecalciferol (Vitamin D3) |
| 500 000IU Vitamin D3 | Experimental | 500 000IU oral vitamin D3 (cholecalciferol) administered at baseline only. Receives: Dietary Supplement: Cholecalciferol (Vitamin D3) |
| Concurrent Control | No intervention | Control group to receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free 25(OH)D
Change in free 25(OH)D from baseline to visit 3 (5-7 days after administration)
Measured: Baseline to visit 3 (5-7 days after administration)
Secondary outcomes (13)
Proportion of total 25(OH)D to free 25(OH)D
Between-group difference in proportion of serum free 25(OH)D to total 25(OH)D at 5, 28 days and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
1, 25(OH)2D
Between-group difference in 1, 25(OH)2D at 5, 28 days and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Ionized calcium
Between-group difference in ionized calcium at 5, 28 days and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Parathyroid Hormone
Between-group difference in PTH at 5, 28 days and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - Alkaline Phosphatase
Between group difference in alkaline phosphatase at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - CTX
Between group difference in CTX at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - PINP
Between group difference in PINP at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - Osteocalcin
Between group difference in Osteocalcin at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Repeated chair stand test score
Between group difference in repeated chair stand test score at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Tandem stand balance test score
Between group difference in tandem stand balance test score at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
8-feet walk course test score
Between group difference in 8-feet walk course test score at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Laying blood pressure
Between group difference in laying blood pressure at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Standing blood pressure
Between group difference in standing blood pressure at 5, 28 and 84 days
Measured: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Osteoporosis Society
- Responsible party
- Sponsor
- Investigators
- Jennifer Walsh, MBChB, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553044
- Sponsor's protocol ID
- STH18850
- Status last verified
- Feb 2019
- First submitted
- 16 Sep 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Shibli-Rahhal A, Paturi B. Variations in parathyroid hormone concentration in patients with low 25 hydroxyvitamin D. Osteoporos Int. 2014 Jul;25(7):1931-6. doi: 10.1007/s00198-014-2687-4. Epub 2014 Mar 20.
PubMed 24647889Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. 2010 May 12;303(18):1815-22. doi: 10.1001/jama.2010.594.
PubMed 20460620Powe CE, Ricciardi C, Berg AH, Erdenesanaa D, Collerone G, Ankers E, Wenger J, Karumanchi SA, Thadhani R, Bhan I. Vitamin D-binding protein modifies the vitamin D-bone mineral density relationship. J Bone Miner Res. 2011 Jul;26(7):1609-16. doi: 10.1002/jbmr.387.
PubMed 21416506Bhan I, Powe CE, Berg AH, Ankers E, Wenger JB, Karumanchi SA, Thadhani RI. Bioavailable vitamin D is more tightly linked to mineral metabolism than total vitamin D in incident hemodialysis patients. Kidney Int. 2012 Jul;82(1):84-9. doi: 10.1038/ki.2012.19. Epub 2012 Mar 7.
PubMed 22398410
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Free 25(OH)D After High Dose in Vitamin D Deficient Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02553044
- Acronym / sponsor ID
- STH18850
- Conditions
- Vitamin D Deficiency, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Osteoporosis Society
- Study start
- Oct 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Sep 2015 (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.
Total 25(OH)D is currently used as a biomarker of vitamin D status. However, there is some debate as to whether total 25(OH)D is the best marker to use.
It has been suggested that free vitamin D may be better because it may be more biologically available.
There are also some uncertainties about how we treat vitamin D deficiency. A single dose is attractive because it is certain that the patient has had the dose and there is no requirement for ongoing compliance, but it is still not clear what the best dose is to give. Also, recent studies have highlighted that high dose vitamin D supplementation may increase the risk of falling in older populations.
The investigators believe that studying how free vitamin D responds to different bolus doses is the best way address some of the current research gaps, including what is the best biomarker of vitamin D status, what is the mechanism of vitamin D toxicity and what is a safe bolus dose to treat deficiency.
The investigators will study changes in total and free 25(OH)D, and also clinical response, to three different bolus doses of vitamin D (50 000IU, 150 000IU and 500 000IU) in 84 vitamin D deficient postmenopausal women, over a three month period with 5 study visits. A concurrent control group of 28 vitamin D sufficient postmenopausal women will also be recruited.
This will allow the investigators to determine how total and free vitamin D change with bolus dosing and whether there is a disproportionate rise in free 25(OH)D with higher doses that may lead to hypercalcemia and falls.
Detailed description
The most commonly used measurement of vitamin D status is serum 25-hydroxyvitamin D (25(OH)D). However there is no clear consensus on the level of 25(OH)D required to protect against adverse effects of deficiency.
One approach is to define deficiency is the level of 25(OH)D at which there is a secondary physiological response, such as a rise in parathyroid hormone. However, this approach has not yielded a clear answer. Total 25(OH)D below 30nmol/l is not always associated with an increased parathyroid hormone (PTH) response, and total 25(OH)D and PTH do not always respond to vitamin D supplementation. This suggests that total 25(OH)D measurement may not be the best biological marker of vitamin D status.
Vitamin D and its metabolites are bound to proteins in the circulation: around 85-90% of 25(OH)D is bound to vitamin D binding protein (DBP), 10-15% is bound to albumin, and less than 1% is in the free form. DBP protects 25(OH)D from degradation and allows a circulating store to accumulate.
The free hormone hypothesis suggests that only the unbound 'free' portion of protein bound hormones is biologically active, and that this should be measured for the accurate assessment of hormone availability. Calculated free 25(OH)D concentrations have been shown to be better correlated to bone mineral density (BMD) than total 25(OH)D in a healthy population and to be more closely related to PTH in patients with end stage renal disease.
The binding capacity of DBP may be overwhelmed in some situations. In female participants treated with an oral dose of 500,000 IU annually for 3 years there was an increase in the risk of falls and fractures that was particularly marked in the three month period after each dose. It has been proposed that there was vitamin D toxicity and possible hypercalcaemia during this period due to the binding capacity of DBP being overwhelmed by the large increase in 25(OH)D with a relatively greater increase in free 25(OH)D. However, free vitamin D and calcium were not measured in the study, so there is not yet evidence to support this hypothesis.
The investigators will study changes in total and free 25(OH)D, and clinical response to three different bolus doses of vitamin D (50,000 units, 150,000 units and 500,000 units) in 84 vitamin D deficient (<30nmol/l) postmenopausal women over three months. This will allow the investigators to determine how free and total 25(OH)D change with bolus dosing and whether there is a disproportionately high rise in free 25(OH)D with higher doses. This will also generate a better understanding of what the optimum bolus dose for treatment of vitamin D deficiency is and whether free 25(OH)D may be a better marker of vitamin D status in some situations.
Aims of the study:
- To determine the effect of three different vitamin D bolus doses on free 25(OH)D and total 25(OH)D in vitamin D deficient post-menopausal women.
- To determine the effect of different vitamin D bolus doses on parameters of calcium metabolism, bone turnover markers and physical function in vitamin D deficient post-menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50 000IU Vitamin D3 | Experimental | Dietary Supplement: Cholecalciferol (Vitamin D3)50 000IU oral vitamin D3 (cholecalciferol) administered at baseline only. |
| 150 000IU Vitamin D3 | Experimental | Dietary Supplement: Cholecalciferol (Vitamin D3)150 000IU oral vitamin D3 (cholecalciferol) administered at baseline only. |
| 500 000IU Vitamin D3 | Experimental | Dietary Supplement: Cholecalciferol (Vitamin D3)500 000IU oral vitamin D3 (cholecalciferol) administered at baseline only. |
| Concurrent Control | No intervention | –Control group to receive no intervention. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caucasian
- 25(OH)D < 30nmol/l for treatment groups or 25(OH)D >50nmol/l for control group
- BMI between 20 kg/m2 and 30kg/m2
- 55 years and over and postmenopausal (at least 5 years since last menstrual period)
- Able and willing to participate in the study and provide written informed consent.
Key exclusion criteria (10 listed)
- History of any long term immobilization (duration greater than three months)
- Pre-diagnosed diabetes mellitus
- High trauma fracture or low trauma fracture less than one year prior to recruitment
- History of or current conditions known to affect vitamin D or bone metabolism, including:
- Chronic renal disease Malabsorption syndromes Diagnosed endocrine disorders Hypercalcaemia Diagnosed restrictive eating disorder
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 |
|---|---|---|
| Cholecalciferol (Vitamin D3)Also: Invita D3Oral vitamin D3 doses made up using 50 000IU ampules of vitamin D3 dissolved in 1ml of olive oil. | Dietary supplement | 150 000IU Vitamin D3, 50 000IU Vitamin D3, 500 000IU Vitamin D3 |
Primary outcome
Free 25(OH)D
Time frame: Baseline to visit 3 (5-7 days after administration)
Change in free 25(OH)D from baseline to visit 3 (5-7 days after administration)
13 secondary outcomes
Proportion of total 25(OH)D to free 25(OH)D
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
1, 25(OH)2D
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Ionized calcium
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Parathyroid Hormone
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - Alkaline Phosphatase
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - CTX
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - PINP
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Bone turnover marker - Osteocalcin
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Repeated chair stand test score
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Tandem stand balance test score
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
8-feet walk course test score
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Laying blood pressure
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) days
Standing blood pressure
Time frame: 5(+/-2) days, 28(+/-3) days and 84(+/-5) 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 15 Feb 2019.
- Background: PubMed 24647889Shibli-Rahhal A, Paturi B. Variations in parathyroid hormone concentration in patients with low 25 hydroxyvitamin D. Osteoporos Int. 2014 Jul;25(7):1931-6. doi: 10.1007/s00198-014-2687-4. Epub 2014 Mar 20.
- Background: PubMed 20460620Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. 2010 May 12;303(18):1815-22. doi: 10.1001/jama.2010.594.
- Background: PubMed 21416506Powe CE, Ricciardi C, Berg AH, Erdenesanaa D, Collerone G, Ankers E, Wenger J, Karumanchi SA, Thadhani R, Bhan I. Vitamin D-binding protein modifies the vitamin D-bone mineral density relationship. J Bone Miner Res. 2011 Jul;26(7):1609-16. doi: 10.1002/jbmr.387.
- Background: PubMed 22398410Bhan I, Powe CE, Berg AH, Ankers E, Wenger JB, Karumanchi SA, Thadhani RI. Bioavailable vitamin D is more tightly linked to mineral metabolism than total vitamin D in incident hemodialysis patients. Kidney Int. 2012 Jul;82(1):84-9. doi: 10.1038/ki.2012.19. Epub 2012 Mar 7.
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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.
Jennifer Walsh, MBChB, PhD principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency and Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 10 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 15 Feb 2019. 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 United Kingdom. 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?
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?
Free 25(OH)D (time frame: Baseline to visit 3 (5-7 days after administration)). 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 NCT02553044, which also lists 4 linked publications.
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 15 Feb 2019.