Diabetes MellitusPhase 4VDDNCT01991054
The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
A Phase 4 study testing vitamin D3 in people with Diabetes Mellitus and Vitamin D Deficiency, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health. There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Vitamin D Deficiency
- What is being tested?
- vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Jan 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written inform consent must be obtained from the patient before any assessment is performed.
- Male or female patient, 18 years or older.
- Diabetes mellitus patients.
- HgA1C levels on randomization above 7.5% in the last 6 months.
- Low 25(OH) vitamin D levels : under 50nmol/l
Who cannot join
- Patient who are unable consume food orally.
- Life expectancy under 7 month.
- Unable to sign inform consent.
- Patient unwilling or unable to comply with study procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health. There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2 diabetes.
The purpose of this study is to evaluate the effect of high dose vitamin D supplementation (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D deficient patients with non-optimally controlled type 2 diabetes mellitus.
Read the detailed description
This is a randomized, double blind, parallel group, clinical trial for 6 months duration.
The study group participants will receive vitamin D supplementation (120,000 IU per month) versus the placebo group for 6 months. glycemic control indexes will be measured in T2DM diagnosed study subjects.
Patient will be randomized 1:1 to one of two treatment groups. Vitamin D group vs placebo group.
Randomization kits will include either vitamin D or vitamin D placebo. Blood screens will be taken prior, after 3 months from randomization and after 6 months from randomization. Anthropometric measurements will be drawn as well, at the same time points.
Determination of sample size In order to find a 0.5 mean difference in HgA1C between the two treatment arms (standard deviation 1.2) a 184 sample size will be required to achieve 80% power, 5% alpha (two sided test).
ADMINISTRATIVE AND LEGAL OBLIGATIONS:
Individual patient's medical information obtained as result of this study is considered confidential and disclosure to third parties.
The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
Source and study documents will be locked under the supervision of the PI- principle investigator for 15 years.
Study documentations and storage The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
All persons authorized to make entries and/or correction on CRF will be included on the investigators team list delegation log.
Study printout and electronic CRF's, ICF's and other study documents will be stored in the at Haemek medical center under the supervision of the PI. All identifying details will be completely erased.
The investigator and staff are responsible for maintaining a comprehensive and centralized filing system of all study- related documentation, suitable for inspection at any time.
- Conditions
- Diabetes Mellitus, Vitamin D Deficiency
- Being tested
- vitamin D3
- Keywords
- Diabetes mellitus, HgA1C, 25(OH) vitamin D, HgA1C levels above 7.5%
- Medical subject headings
- Diabetes Mellitus, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
Also called Cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 supplementation | Experimental | The study group participants will receive vitamin D3 supplementation (120,000 I.U per month)for 6 months Receives: Dietary Supplement: vitamin D3 |
| placebo group | Placebo comparator | placebo group, 15 ml per month for 6 months Receives: Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hba1c (%) in study groups
We assume that the treatment with vitamin D will improve diabetes control, as assessed by Hba1c . The expected reduction in Hba1c levels will be 0.5%.
Measured: 2 years
Secondary outcomes (9)
Lipid profile
Total cholesterol, LDL cholesterol , HDL cholesterol, non HDL cholesterol, Triglycerides
Measured: 2 years
C-reactive protein
Measured: 2 years
Body Weight
Measured: 2 years
Blood Pressure
Measured: 2 years
serum calcium
Measured: 2 years
serum phosphore
Measured: 2 years
serum PTH
Measured: 2 years
serum creatinine
Measured: 2 years
serum albumin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, avraham ishay, HaEmek Medical Center, Israel
- Investigators
- avraham ishay, M.D, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991054
- Sponsor's protocol ID
- HGA1C vs D
- Acronym
- VDD
- Status last verified
- Sep 2016
- First submitted
- 7 Nov 2013
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462Bikle D. Nonclassic actions of vitamin D. J Clin Endocrinol Metab. 2009 Jan;94(1):26-34. doi: 10.1210/jc.2008-1454. Epub 2008 Oct 14.
PubMed 18854395Maalouf NM. The noncalciotropic actions of vitamin D: recent clinical developments. Curr Opin Nephrol Hypertens. 2008 Jul;17(4):408-15. doi: 10.1097/MNH.0b013e3283040c99.
PubMed 18660678Toubi E, Shoenfeld Y. The role of vitamin D in regulating immune responses. Isr Med Assoc J. 2010 Mar;12(3):174-5. No abstract available.
PubMed 20684184Peelen E, Knippenberg S, Muris AH, Thewissen M, Smolders J, Tervaert JW, Hupperts R, Damoiseaux J. Effects of vitamin D on the peripheral adaptive immune system: a review. Autoimmun Rev. 2011 Oct;10(12):733-43. doi: 10.1016/j.autrev.2011.05.002. Epub 2011 May 18.
PubMed 21621002Girgis CM, Clifton-Bligh RJ, Hamrick MW, Holick MF, Gunton JE. The roles of vitamin D in skeletal muscle: form, function, and metabolism. Endocr Rev. 2013 Feb;34(1):33-83. doi: 10.1210/er.2012-1012. Epub 2012 Nov 20.
PubMed 23169676Wang L, Song Y, Manson JE, Pilz S, Marz W, Michaelsson K, Lundqvist A, Jassal SK, Barrett-Connor E, Zhang C, Eaton CB, May HT, Anderson JL, Sesso HD. Circulating 25-hydroxy-vitamin D and risk of cardiovascular disease: a meta-analysis of prospective studies. Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):819-29. doi: 10.1161/CIRCOUTCOMES.112.967604. Epub 2012 Nov 13.
PubMed 23149428Binkley N, Ramamurthy R, Krueger D. Low vitamin D status: definition, prevalence, consequences, and correction. Endocrinol Metab Clin North Am. 2010 Jun;39(2):287-301, table of contents. doi: 10.1016/j.ecl.2010.02.008.
PubMed 20511052Mithal A, Wahl DA, Bonjour JP, Burckhardt P, Dawson-Hughes B, Eisman JA, El-Hajj Fuleihan G, Josse RG, Lips P, Morales-Torres J; IOF Committee of Scientific Advisors (CSA) Nutrition Working Group. Global vitamin D status and determinants of hypovitaminosis D. Osteoporos Int. 2009 Nov;20(11):1807-20. doi: 10.1007/s00198-009-0954-6. Epub 2009 Jun 19.
PubMed 19543765Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet. 2005 Apr 9-15;365(9467):1333-46. doi: 10.1016/S0140-6736(05)61032-X.
PubMed 15823385Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
PubMed 19896746Takiishi T, Gysemans C, Bouillon R, Mathieu C. Vitamin D and diabetes. Rheum Dis Clin North Am. 2012 Feb;38(1):179-206. doi: 10.1016/j.rdc.2012.03.015. Epub 2012 Apr 12.
PubMed 22525851Cade C, Norman AW. Vitamin D3 improves impaired glucose tolerance and insulin secretion in the vitamin D-deficient rat in vivo. Endocrinology. 1986 Jul;119(1):84-90. doi: 10.1210/endo-119-1-84.
PubMed 3013599Norman AW, Frankel JB, Heldt AM, Grodsky GM. Vitamin D deficiency inhibits pancreatic secretion of insulin. Science. 1980 Aug 15;209(4458):823-5. doi: 10.1126/science.6250216.
PubMed 6250216Norman AW. Minireview: vitamin D receptor: new assignments for an already busy receptor. Endocrinology. 2006 Dec;147(12):5542-8. doi: 10.1210/en.2006-0946. Epub 2006 Aug 31.
PubMed 16946007
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT01991054
- Acronym / sponsor ID
- VDD / HGA1C vs D
- Conditions
- Diabetes Mellitus, Vitamin D Deficiency
- Keywords
- Diabetes mellitus, HgA1C, 25(OH) vitamin D, HgA1C levels above 7.5%
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Nov 2013 (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 plays a key role in keeping normal mineral balance and maintaining bone health. There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2 diabetes.
The purpose of this study is to evaluate the effect of high dose vitamin D supplementation (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D deficient patients with non-optimally controlled type 2 diabetes mellitus.
Detailed description
This is a randomized, double blind, parallel group, clinical trial for 6 months duration.
The study group participants will receive vitamin D supplementation (120,000 IU per month) versus the placebo group for 6 months. glycemic control indexes will be measured in T2DM diagnosed study subjects.
Patient will be randomized 1:1 to one of two treatment groups. Vitamin D group vs placebo group.
Randomization kits will include either vitamin D or vitamin D placebo. Blood screens will be taken prior, after 3 months from randomization and after 6 months from randomization. Anthropometric measurements will be drawn as well, at the same time points.
Determination of sample size In order to find a 0.5 mean difference in HgA1C between the two treatment arms (standard deviation 1.2) a 184 sample size will be required to achieve 80% power, 5% alpha (two sided test).
ADMINISTRATIVE AND LEGAL OBLIGATIONS:
Individual patient's medical information obtained as result of this study is considered confidential and disclosure to third parties.
The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
Source and study documents will be locked under the supervision of the PI- principle investigator for 15 years.
Study documentations and storage The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
All persons authorized to make entries and/or correction on CRF will be included on the investigators team list delegation log.
Study printout and electronic CRF's, ICF's and other study documents will be stored in the at Haemek medical center under the supervision of the PI. All identifying details will be completely erased.
The investigator and staff are responsible for maintaining a comprehensive and centralized filing system of all study- related documentation, suitable for inspection at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 supplementation | Experimental | Dietary Supplement: vitamin D3The study group participants will receive vitamin D3 supplementation (120,000 I.U per month)for 6 months |
| placebo group | Placebo comparator | Dietary Supplement: vitamin D3placebo group, 15 ml per month for 6 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written inform consent must be obtained from the patient before any assessment is performed.
- Male or female patient, 18 years or older.
- Diabetes mellitus patients.
- HgA1C levels on randomization above 7.5% in the last 6 months.
- Low 25(OH) vitamin D levels : under 50nmol/l
Key exclusion criteria (4 listed)
- Patient who are unable consume food orally.
- Life expectancy under 7 month.
- Unable to sign inform consent.
- Patient unwilling or unable to comply with study procedure.
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 D3Also: Cholecalciferol | Dietary supplement | placebo group, vitamin D3 supplementation |
Primary outcome
Change in Hba1c (%) in study groups
Time frame: 2 years
We assume that the treatment with vitamin D will improve diabetes control, as assessed by Hba1c . The expected reduction in Hba1c levels will be 0.5%.
9 secondary outcomes
Lipid profile
Time frame: 2 years
C-reactive protein
Time frame: 2 years
Body Weight
Time frame: 2 years
Blood Pressure
Time frame: 2 years
serum calcium
Time frame: 2 years
serum phosphore
Time frame: 2 years
serum PTH
Time frame: 2 years
serum creatinine
Time frame: 2 years
serum albumin
Time frame: 2 years
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 27 Feb 2018.
- Background: PubMed 17634462Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Background: PubMed 18854395Bikle D. Nonclassic actions of vitamin D. J Clin Endocrinol Metab. 2009 Jan;94(1):26-34. doi: 10.1210/jc.2008-1454. Epub 2008 Oct 14.
- Background: PubMed 18660678Maalouf NM. The noncalciotropic actions of vitamin D: recent clinical developments. Curr Opin Nephrol Hypertens. 2008 Jul;17(4):408-15. doi: 10.1097/MNH.0b013e3283040c99.
- Background: PubMed 20684184Toubi E, Shoenfeld Y. The role of vitamin D in regulating immune responses. Isr Med Assoc J. 2010 Mar;12(3):174-5. No abstract available.
- Background: PubMed 21621002Peelen E, Knippenberg S, Muris AH, Thewissen M, Smolders J, Tervaert JW, Hupperts R, Damoiseaux J. Effects of vitamin D on the peripheral adaptive immune system: a review. Autoimmun Rev. 2011 Oct;10(12):733-43. doi: 10.1016/j.autrev.2011.05.002. Epub 2011 May 18.
- Background: PubMed 23169676Girgis CM, Clifton-Bligh RJ, Hamrick MW, Holick MF, Gunton JE. The roles of vitamin D in skeletal muscle: form, function, and metabolism. Endocr Rev. 2013 Feb;34(1):33-83. doi: 10.1210/er.2012-1012. Epub 2012 Nov 20.
- Background: PubMed 23149428Wang L, Song Y, Manson JE, Pilz S, Marz W, Michaelsson K, Lundqvist A, Jassal SK, Barrett-Connor E, Zhang C, Eaton CB, May HT, Anderson JL, Sesso HD. Circulating 25-hydroxy-vitamin D and risk of cardiovascular disease: a meta-analysis of prospective studies. Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):819-29. doi: 10.1161/CIRCOUTCOMES.112.967604. Epub 2012 Nov 13.
- Background: PubMed 20511052Binkley N, Ramamurthy R, Krueger D. Low vitamin D status: definition, prevalence, consequences, and correction. Endocrinol Metab Clin North Am. 2010 Jun;39(2):287-301, table of contents. doi: 10.1016/j.ecl.2010.02.008.
- Background: PubMed 19543765Mithal A, Wahl DA, Bonjour JP, Burckhardt P, Dawson-Hughes B, Eisman JA, El-Hajj Fuleihan G, Josse RG, Lips P, Morales-Torres J; IOF Committee of Scientific Advisors (CSA) Nutrition Working Group. Global vitamin D status and determinants of hypovitaminosis D. Osteoporos Int. 2009 Nov;20(11):1807-20. doi: 10.1007/s00198-009-0954-6. Epub 2009 Jun 19.
- Background: PubMed 15823385Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet. 2005 Apr 9-15;365(9467):1333-46. doi: 10.1016/S0140-6736(05)61032-X.
- Background: PubMed 19896746Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
- Background: PubMed 22525851Takiishi T, Gysemans C, Bouillon R, Mathieu C. Vitamin D and diabetes. Rheum Dis Clin North Am. 2012 Feb;38(1):179-206. doi: 10.1016/j.rdc.2012.03.015. Epub 2012 Apr 12.
- 41\. "Vitamin D and Calcium: Updated Dietary Reference Intakes". Nutrition and Healthy Eating. Health Canada. Retrieved 2012-06-13.Link provided by the sponsor.
- 42\. U.S. Food and Drug Administration: Guidance for Industry: A Food labeling Guide.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
avraham ishay, M.D principal investigator
haemek medical center
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 vitamin D3 in people with Diabetes Mellitus and Vitamin D Deficiency, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 4 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 27 Feb 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 Israel. 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 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?
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?
Change in Hba1c (%) in study groups (time frame: 2 years). 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 NCT01991054, which also lists 39 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 27 Feb 2018.