Vitamin D DeficiencyPhase 2NCT02735200
Topical Delivery of Vitamin D3 as Vitamin D Supplementation
A Phase 2 study testing Application of topical vitamin d3 (Top-D) and Application of Aloe vera gel in people with Vitamin D Deficiency, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
After obtaining the approval from the IRB of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Application of topical vitamin d3 (Top-D) and Application of Aloe vera gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2016to 30 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all men and women with vitamin D insufficiency and deficiency Must be able to apple the topical vitamin D3 Must be willing to sign and informed consent
Who cannot join
- Those who have normal 25OHD levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Delivery of Vitamin D3: A Randomized Controlled Trial (RCT)
After obtaining the approval from the IRB of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.
Read the detailed description
After obtaining the approval from the Institutional Review Board (IRB) of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) I gram gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.
- Conditions
- Vitamin D Deficiency
- Being tested
- Application of topical vitamin d3 (Top-D), Application of Aloe vera gel
- 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.
Application of topical vitamin d3 (Top-D)Drug
Also called Topical vitamin D3, TOP-D
Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days
Application of Aloe vera gelOther
aloe vera gel will be applied
Dosage: 1 gram Duration: 120 days Frequency: Daily
| Study group | Role | What they receive |
|---|---|---|
| Topical Vitamin D3 application | Experimental | Intervention is Application of topical Vitamin D3 Frequency: Daily Dosage: 1 gram (5000 IU) Duration: 120 days Receives: Drug: Application of topical vitamin d3 (Top-D) |
| Aloe vera gel Application | Active comparator | Application of Aloe vera gel will be carried out Dosage: 1 gram Frequency: Daily Duration: 120 days Receives: Other: Application of Aloe vera gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Serum 25 OHD Level Pre-treatment and Post Treatment
Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.
Measured: baseline and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naif AlMasoud, MD, PhD, Study director, University of Dammam, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735200
- Sponsor's protocol ID
- DammamU
- Status last verified
- May 2017
- First submitted
- 12 Mar 2016
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Riccio PA, Zingaretti C, Milani M, Ricci Petitoni G, Monti G, Pavanello PM. [Thymoma: diagnosis and surgical treatment]. Minerva Chir. 1996 Sep;51(9):663-7. Italian.
PubMed 9082230Sadat-Ali M, AlElq A, Al-Turki H, Al-Mulhim F, Al-Ali A. Vitamin D levels in healthy men in eastern Saudi Arabia. Ann Saudi Med. 2009 Sep-Oct;29(5):378-82. doi: 10.4103/0256-4947.55168.
PubMed 19700896Elsammak MY, Al-Wosaibi AA, Al-Howeish A, Alsaeed J. Vitamin d deficiency in Saudi Arabs. Horm Metab Res. 2010 May;42(5):364-8. doi: 10.1055/s-0030-1248296. Epub 2010 Mar 8.
PubMed 20213587Al-Elq AH. The status of Vitamin D in medical students in the preclerkship years of a Saudi medical school. J Family Community Med. 2012 May;19(2):100-4. doi: 10.4103/2230-8229.98293.
PubMed 22870413Grant AM, Avenell A, Campbell MK, McDonald AM, MacLennan GS, McPherson GC, Anderson FH, Cooper C, Francis RM, Donaldson C, Gillespie WJ, Robinson CM, Torgerson DJ, Wallace WA; RECORD Trial Group. Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial. Lancet. 2005 May 7-13;365(9471):1621-8. doi: 10.1016/S0140-6736(05)63013-9.
PubMed 15885294Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, Baverstock M, Birks Y, Dumville J, Francis R, Iglesias C, Puffer S, Sutcliffe A, Watt I, Torgerson DJ. Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. BMJ. 2005 Apr 30;330(7498):1003. doi: 10.1136/bmj.330.7498.1003.
PubMed 15860827Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, Bassford T, Beresford SA, Black HR, Blanchette P, Bonds DE, Brunner RL, Brzyski RG, Caan B, Cauley JA, Chlebowski RT, Cummings SR, Granek I, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Johnson KC, Judd H, Kotchen JM, Kuller LH, Langer RD, Lasser NL, Limacher MC, Ludlam S, Manson JE, Margolis KL, McGowan J, Ockene JK, O'Sullivan MJ, Phillips L, Prentice RL, Sarto GE, Stefanick ML, Van Horn L, Wactawski-Wende J, Whitlock E, Anderson GL, Assaf AR, Barad D; Women's Health Initiative Investigators. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med. 2006 Feb 16;354(7):669-83. doi: 10.1056/NEJMoa055218.
PubMed 16481635Nikolaus T, Kruse W, Bach M, Specht-Leible N, Oster P, Schlierf G. Elderly patients' problems with medication. An in-hospital and follow-up study. Eur J Clin Pharmacol. 1996;49(4):255-9. doi: 10.1007/BF00226324.
PubMed 8857069Thomas BJ, Finnin BC. The transdermal revolution. Drug Discov Today. 2004 Aug 15;9(16):697-703. doi: 10.1016/S1359-6446(04)03180-0.
PubMed 15341783Shi Y, Wei Z, Zhao H, Liu T, Dong A, Zhang J. Electrospinning of ibuprofen-loaded composite nanofibers for improving the performances of transdermal patches. J Nanosci Nanotechnol. 2013 Jun;13(6):3855-63. doi: 10.1166/jnn.2013.7157.
PubMed 23862418Derry S, Moore RA. Topical capsaicin (low concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD010111. doi: 10.1002/14651858.CD010111.
PubMed 22972149Aggarwal N, Goindi S. Preparation and in vivo evaluation of solid lipid nanoparticles of griseofulvin for dermal use. J Biomed Nanotechnol. 2013 Apr;9(4):564-76. doi: 10.1166/jbn.2013.1569.
PubMed 23621015Ahad A, Al-Jenoobi FI, Al-Mohizea AM, Aqil M, Kohli K. Transdermal delivery of calcium channel blockers for hypertension. Expert Opin Drug Deliv. 2013 Aug;10(8):1137-53. doi: 10.1517/17425247.2013.783562. Epub 2013 Mar 26.
PubMed 23527660Goodman MP. Are all estrogens created equal? A review of oral vs. transdermal therapy. J Womens Health (Larchmt). 2012 Feb;21(2):161-9. doi: 10.1089/jwh.2011.2839. Epub 2011 Oct 19.
PubMed 22011208Segal E, Zinman C, Raz B, Ish-Shalom S. Low patient compliance--a major negative factor in achieving vitamin D adequacy in elderly hip fracture patients supplemented with 800IU of vitamin D3 daily. Arch Gerontol Geriatr. 2009 Nov-Dec;49(3):364-7. doi: 10.1016/j.archger.2008.12.001. Epub 2009 Jan 14.
PubMed 19147237
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Delivery of Vitamin D3: A Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT02735200
- Acronym / sponsor ID
- DammamU
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After obtaining the approval from the IRB of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.
Detailed description
After obtaining the approval from the Institutional Review Board (IRB) of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) I gram gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- assignment
| Arm | Type | Receives |
|---|---|---|
| Topical Vitamin D3 application | Experimental | Drug: Application of topical vitamin d3 (Top-D)Intervention is Application of topical Vitamin D3 Frequency: Daily Dosage: 1 gram (5000 IU) Duration: 120 days |
| Aloe vera gel Application | Active comparator | Other: Application of Aloe vera gelApplication of Aloe vera gel will be carried out Dosage: 1 gram Frequency: Daily Duration: 120 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all men and women with vitamin D insufficiency and deficiency Must be able to apple the topical vitamin D3 Must be willing to sign and informed consent
Key exclusion criteria (1 listed)
- Those who have normal 25OHD levels
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 |
|---|---|---|
| Application of topical vitamin d3 (Top-D)Also: Topical vitamin D3, TOP-DTopical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days | Drug | Topical Vitamin D3 application |
| Application of Aloe vera gelaloe vera gel will be applied Dosage: 1 gram Duration: 120 days Frequency: Daily | Other | Aloe vera gel Application |
Primary outcome
Level of Serum 25 OHD Level Pre-treatment and Post Treatment
Time frame: baseline and 5 months
Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9082230Riccio PA, Zingaretti C, Milani M, Ricci Petitoni G, Monti G, Pavanello PM. [Thymoma: diagnosis and surgical treatment]. Minerva Chir. 1996 Sep;51(9):663-7. Italian.
- Background: PubMed 19700896Sadat-Ali M, AlElq A, Al-Turki H, Al-Mulhim F, Al-Ali A. Vitamin D levels in healthy men in eastern Saudi Arabia. Ann Saudi Med. 2009 Sep-Oct;29(5):378-82. doi: 10.4103/0256-4947.55168.
- Background: PubMed 20213587Elsammak MY, Al-Wosaibi AA, Al-Howeish A, Alsaeed J. Vitamin d deficiency in Saudi Arabs. Horm Metab Res. 2010 May;42(5):364-8. doi: 10.1055/s-0030-1248296. Epub 2010 Mar 8.
- Background: PubMed 22870413Al-Elq AH. The status of Vitamin D in medical students in the preclerkship years of a Saudi medical school. J Family Community Med. 2012 May;19(2):100-4. doi: 10.4103/2230-8229.98293.
- Background: PubMed 15885294Grant AM, Avenell A, Campbell MK, McDonald AM, MacLennan GS, McPherson GC, Anderson FH, Cooper C, Francis RM, Donaldson C, Gillespie WJ, Robinson CM, Torgerson DJ, Wallace WA; RECORD Trial Group. Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial. Lancet. 2005 May 7-13;365(9471):1621-8. doi: 10.1016/S0140-6736(05)63013-9.
- Background: PubMed 15860827Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, Baverstock M, Birks Y, Dumville J, Francis R, Iglesias C, Puffer S, Sutcliffe A, Watt I, Torgerson DJ. Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. BMJ. 2005 Apr 30;330(7498):1003. doi: 10.1136/bmj.330.7498.1003.
- Background: PubMed 16481635Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, Bassford T, Beresford SA, Black HR, Blanchette P, Bonds DE, Brunner RL, Brzyski RG, Caan B, Cauley JA, Chlebowski RT, Cummings SR, Granek I, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Johnson KC, Judd H, Kotchen JM, Kuller LH, Langer RD, Lasser NL, Limacher MC, Ludlam S, Manson JE, Margolis KL, McGowan J, Ockene JK, O'Sullivan MJ, Phillips L, Prentice RL, Sarto GE, Stefanick ML, Van Horn L, Wactawski-Wende J, Whitlock E, Anderson GL, Assaf AR, Barad D; Women's Health Initiative Investigators. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med. 2006 Feb 16;354(7):669-83. doi: 10.1056/NEJMoa055218.
- Background: PubMed 8857069Nikolaus T, Kruse W, Bach M, Specht-Leible N, Oster P, Schlierf G. Elderly patients' problems with medication. An in-hospital and follow-up study. Eur J Clin Pharmacol. 1996;49(4):255-9. doi: 10.1007/BF00226324.
- Background: PubMed 15341783Thomas BJ, Finnin BC. The transdermal revolution. Drug Discov Today. 2004 Aug 15;9(16):697-703. doi: 10.1016/S1359-6446(04)03180-0.
- Background: PubMed 23862418Shi Y, Wei Z, Zhao H, Liu T, Dong A, Zhang J. Electrospinning of ibuprofen-loaded composite nanofibers for improving the performances of transdermal patches. J Nanosci Nanotechnol. 2013 Jun;13(6):3855-63. doi: 10.1166/jnn.2013.7157.
- Background: PubMed 22972149Derry S, Moore RA. Topical capsaicin (low concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD010111. doi: 10.1002/14651858.CD010111.
- Background: PubMed 23621015Aggarwal N, Goindi S. Preparation and in vivo evaluation of solid lipid nanoparticles of griseofulvin for dermal use. J Biomed Nanotechnol. 2013 Apr;9(4):564-76. doi: 10.1166/jbn.2013.1569.
- Individual participant dataSharing planned: Yes
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Naif AlMasoud, MD, PhD study director
University of Dammam, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Application of topical vitamin d3 (Top-D) and Application of Aloe vera gel in people with Vitamin D Deficiency, run by Imam Abdulrahman Bin Faisal University 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 1 inclusion and 1 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 14 Jun 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 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. 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 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Level of Serum 25 OHD Level Pre-treatment and Post Treatment (time frame: baseline and 5 months). 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 NCT02735200, which also lists 18 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 14 Jun 2017.