Diabetes Mellitus Type 2Phase 3NCT01585051
Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D
A Phase 3 study testing 25(OH) vitamin D and 0.9 % NaCl in people with Diabetes Mellitus Type 2, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
Trial summary
The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- 25(OH) vitamin D and 0.9 % NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Jun 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, ages ≥18 years
- Official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment
- Independent living at home
- On stable regimen of BP meds (if any) with BP well controlled and/or K supplement (if any) for 2 months and which is deemed unlikely to change during the study
- Stable glucose control for 2 months by any approved method including insulin
Who cannot join
- Patients with type 1 diabetes (or insulin-requiring diabetes of unclear type)
- Patients on hemodialysis, with hyperparathyroidism or active cancer disease
- Patients with known metabolic bone disease
- Laboratory evidence of kidney (eGFR < 60 ml/min) or liver disease
- Dietary calcium intake exceeding 1500mg/d (as estimated by dietary history)
- 25(OH) vitamin D levels at baseline > 70 nmol/L
Show all 12Show fewer
- Calciuria (> 8 mmol/24 hours as measured by 24 hour urine collections)
- Hypo- and hypercalcemias and hypo- and hyperphosphatemias of any cause
- Medications that affect vitamin D metabolism (e.g. antiepileptic drugs, calcimimetics, 1-34 PTH (Forsteo) vitamin D therapy over and above 400U daily 6 months prior to enrollment and during the study)
- Foreseeable need for adaptation of either glucose- or blood pressure lowering during the next 6 months as decided by the family physician or the treating diabetologist - see above
- History of binge eating or wt gain or loss exceeding 6 kg in past 18 months
- Patients on any type of inhibitors of plasma coagulation (i.e. coumarine, heparins)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of medicine, Kantonsspital Bruderholz
Bruderholz/Basel, Basel-Landschaft, CH-4101
About this study
Official title: Effect of Administration of 25(OH) Vitamin on Mean 24 Hour Blood Pressure and HBA1c Levels in Patients With Stable Type 2 Diabetes Mellitus
The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- 25(OH) vitamin D, 0.9 % NaCl
- Keywords
- vitamin D, blood pressure, typ 2 diabetes mellitus, blood glucose, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25(OH) vitamin DDrug
300 000 U intramuscularly, one dosage, in subjects with 25 (OH) vit D levels below 80 nmol/L, another dosage of 150 000 U after 3 months if 25(OH)vit D levels continue to be below 80 nmol/L.
0.9 % NaClDrug
1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Active comparator | Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D Receives: Drug: 25(OH) vitamin D |
| placebo | Placebo comparator | administration of 0.9 % NaCl as a placebo Receives: Drug: 0.9 % NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HBA1-c levels
Measured: 3 and 6 months
24 hour mean blood pressure
Measured: 3 and 6 months
Secondary outcomes (2)
plasma glucose
Measured: 3 and 6 months
HOMA
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJun 2010
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 Diabetes Mellitus Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baselland Bruderholz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reto Krapf, Kantonsspital Baselland Bruderholz
- Investigators
- Reto Krapf, MD, Principal investigator, Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585051
- Sponsor's protocol ID
- x335/08
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jehle S, Lardi A, Felix B, Hulter HN, Stettler C, Krapf R. Effect of large doses of parenteral vitamin D on glycaemic control and calcium/phosphate metabolism in patients with stable type 2 diabetes mellitus: a randomised, placebo-controlled, prospective pilot study. Swiss Med Wkly. 2014 Mar 20;144:w13942. doi: 10.4414/smw.2014.13942.
PubMed 24652692
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Administration of 25(OH) Vitamin on Mean 24 Hour Blood Pressure and HBA1c Levels in Patients With Stable Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01585051
- Acronym / sponsor ID
- x335/08
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- vitamin D, blood pressure, typ 2 diabetes mellitus, blood glucose, HbA1c
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Kantonsspital Baselland BruderholzUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Apr 2012 (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.
The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Active comparator | Drug: 25(OH) vitamin DIntervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D |
| placebo | Placebo comparator | Drug: 0.9 % NaCladministration of 0.9 % NaCl as a placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, ages ≥18 years
- Official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment
- Independent living at home
- On stable regimen of BP meds (if any) with BP well controlled and/or K supplement (if any) for 2 months and which is deemed unlikely to change during the study
- Stable glucose control for 2 months by any approved method including insulin
Key exclusion criteria (12 listed)
- Patients with type 1 diabetes (or insulin-requiring diabetes of unclear type)
- Patients on hemodialysis, with hyperparathyroidism or active cancer disease
- Patients with known metabolic bone disease
- Laboratory evidence of kidney (eGFR < 60 ml/min) or liver disease
- Dietary calcium intake exceeding 1500mg/d (as estimated by dietary history)
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 |
|---|---|---|
| 25(OH) vitamin D300 000 U intramuscularly, one dosage, in subjects with 25 (OH) vit D levels below 80 nmol/L, another dosage of 150 000 U after 3 months if 25(OH)vit D levels continue to be below 80 nmol/L. | Drug | vitamin D |
| 0.9 % NaCl1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months | Drug | placebo |
Primary outcome
Change in HBA1-c levels
Time frame: 3 and 6 months
24 hour mean blood pressure
Time frame: 3 and 6 months
2 secondary outcomes
plasma glucose
Time frame: 3 and 6 months
HOMA
Time frame: 6 months
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 25 Apr 2012.
- Derived from this study: PubMed 24652692Jehle S, Lardi A, Felix B, Hulter HN, Stettler C, Krapf R. Effect of large doses of parenteral vitamin D on glycaemic control and calcium/phosphate metabolism in patients with stable type 2 diabetes mellitus: a randomised, placebo-controlled, prospective pilot study. Swiss Med Wkly. 2014 Mar 20;144:w13942. doi: 10.4414/smw.2014.13942.
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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.
Reto Krapf, MD principal investigator
Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 25(OH) vitamin D and 0.9 % NaCl in people with Diabetes Mellitus Type 2, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
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 12 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 25 Apr 2012. 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 Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 HBA1-c levels (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. 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 NCT01585051, 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 25 Apr 2012.