Sub-optimal Vitamin D StatusPhase 2NCT01476501
Vitamin D Supplementation in Diabetic Nephropathy
A Phase 2 study testing Vitamin D3 in people with Sub-optimal Vitamin D Status and Bone Disease, run by University of Alberta at 1 site in Canada.
Trial summary
Diabetes is a life-long disease that is getting more common in Canada. One of the most common problems in people with kidney disease is diabetes and low bone mineral density (BMD). This can lead to a higher chance for broken bones, infection and life-long health problems. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sub-optimal Vitamin D Status, Bone Disease, Diabetic Nephropathy
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Dec 2015
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnoses of diabetes (type 1 or 2) and stage 2-4 chronic kidney disease (glomerular filtration rate: 15-89 ml/min/1.73m2)
Who cannot join
- Patients with co-morbid conditions known to affect vitamin D metabolism including gastrointestinal, liver, rheumatoid or bone disorders (e.g. hyperthyroidism, untreated celiac disease, cancer, Paget's disease, sarcoidosis, malabsorption, etc). Individuals with severe, permanent vision impairment will be excluded as this will preclude them from reading supplement labels accurately and safely. Pregnant women will be excluded as DXA scans are not recommended during pregnancy. Patients weighing >136kg will be excluded as the DXA table cannot accommodate this weight.
- Patients on drug therapy known to interfere with vitamin D (e.g. oral glucocorticoids, cholestyramine, colestipol, mineral oil, Orlistat, digoxin, antacids).
- Patients with stage 5 CKD (GFR <15ml/min/1.73m2), receiving dialysis or on kidney transplant list.
- Patients with pre-existing hypercalcemia (>2.75mmol/l), hyperphosphatemia (>2.0mmol/l), severe hyperparathyroidism (PTH >600pg/ml), and serum 25(OH)D >200nmol/l.
- Patients with serum 25(OH)D <37.5nmol/l at time of study entry/screening to control for correction of vitamin D deficiency.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Research Unit, University of Alberta
Edmonton, Alberta, T6G 0K2
About this study
Official title: Vitamin D Supplementation and Bone Health in Adults With Diabetic Nephropathy
Diabetes is a life-long disease that is getting more common in Canada. One of the most common problems in people with kidney disease is diabetes and low bone mineral density (BMD). This can lead to a higher chance for broken bones, infection and life-long health problems. The most common reason for having low BMD is not getting enough vitamin D (Vit D) in your diet and not having enough sunlight. This is very common in Canada (especially in northern Alberta) because winter is very long. Most people also don't eat or drink enough foods that are high in Vit D (like milk) and so they don't have enough Vit D in their body to make healthy bones. This can mean the only way to get enough Vit D in your body for your bones when you have kidney disease is to take some extra vitamin D in a pill. Most people are not aware that they have poor bone health until they break a bone. Broken bones can really hurt and can prevent a person from being able to walk and take care of themselves. Right now, we are not sure exactly how much Vit D people with diabetes and kidney disease need to take to prevent them from having low BMD or how often they need to take it. Our plan is to study the effect of two ways to take Vit D pills (every day or once a month) on overall Vit D status and on bone health in adult patients with diabetes and chronic kidney disease and see how this influences their quality of life.
Hypotheses:
- Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result in significantly improved overall vitamin D status and improved markers of bone health in adult patients with diabetic nephropathy.
- Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved patient adherence and satisfaction with vitamin D supplementation when compared to daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health parameters, which will result in an increased quality of life and sense of well-being.
Read the detailed description
Abstract:
Vitamin D has a well-established role in bone health and the prevention of fractures which are associated with increased morbidity and mortality, and reduced quality of life. However, many individuals have sub-optimal vitamin D status (<75nmol/l), and risk increases with geographical location, age, ethnicity, inadequate dietary intake and disease. Diabetes and kidney disease are two chronic diseases associated with both poor bone health and suboptimal vitamin D status. Individuals with diabetes and chronic kidney disease who live in northern Alberta are at a particular risk for suboptimal vitamin D status and poor bone health due to dietary restrictions on vitamin D rich foods (e.g. milk products that are also high in phosphorus and carbohydrates), negligible cutaneous synthesis during the long winter months, and reduced renal capacity to synthesize active vitamin D (1,25(OH)2D). In the general Canadian population, few are able to meet dietary recommendations for vitamin D intake through diet alone and often rely on vitamin D supplements. The need for vitamin D supplementation is increased in diabetics with nephropathy, however the optimal dose and strategy for vitamin D supplementation is unknown. Like other chronic diseases, adherence to therapy is a major issue in this population. With each additional chronic disease an individual has, their adherence to therapy and quality of life decreases. Adherence to vitamin D therapy is known to be particularly poor. This may be related to the silent nature of bone disease, as poor bone health is often not identified until a fracture has occurred. Novel strategies to vitamin D supplementation are needed to prevent poor bone health and fractures, and the resulting decline in quality of life that ensues. Therefore it is important to identify a vitamin D supplementation strategy that increases adherence to vitamin D supplementation and improves vitamin D status and bone health in adults with diabetes and nephropathy.
Objectives:
- Examine the impact of two approaches to oral high dose vitamin D supplementation (2,000 IU/day versus 40,000 IU/month for six months) on overall vitamin D status and markers of bone turnover in adult patients with diabetic nephropathy.
- Examine daily versus monthly vitamin D supplementation strategies in regards to adherence, satisfaction and quality of life in adult patients with diabetic nephropathy.
Hypotheses:
- Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result in significantly improved overall vitamin D status and improved markers of bone health in adult patients with diabetic nephropathy.
- Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved patient adherence and satisfaction with vitamin D supplementation when compared to daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health parameters, which will result in an increased quality of life and sense of well-being.
- Being tested
- Vitamin D3
- Keywords
- vitamin D, bone health, diabetes, nephropathy
- Medical subject headings
- Bone Diseases, Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Daily: Jamieson NPN 80017530, Monthly: EURO-Pharm DIN 02253178
Randomized into 1 of 2 oral vitamin D3 softgel capsule supplementation strategies: 1) 2,000 IU/day (2 x 1,000IU/capsule each day) or 2) 40,000 IU/month (4 x 10,000IU/capsule last day of each month), for 6 months each.
| Study group | Role | What they receive |
|---|---|---|
| 2,000 IU/day vitamin D | Experimental | 2,000 IU/day vitamin D for 6 months (n=60). Receives: Drug: Vitamin D3 |
| 40,000 IU/month vitamin D | Experimental | 40,000 IU/month for 6 months (n=60). Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum vitamin D from baseline to 3 and 6 months
Changes in serum 25(OH)D and 1,25(OH)D between baseline, 3 and 6 months between individuals and between study arms.
Measured: Change from baseline to 3 and 6 months
Secondary outcomes (7)
Change in adherence to supplement between 3 and 6 months
Participant adherence to and acceptance of supplementation strategy will be assessed using a validated questionnaire for adherence in adults with chronic disease.
Measured: 3 and 6 months
Change in health related quality of life from baseline to 6 months
The validated health related quality of life questionnaire SF-36 is often used in renal populations and will be completed at baseline and at 6 months.
Measured: baseline and 6 months
Change in dietary intake from baseline to 3 and 6 months
3-day food intake records are a validated tool to assess dietary intake, and will consist of 2 weekdays and 1 weekend day. They will be verified by a Registered Dietitian and analyzed using Food Processor (SQL v10 ESHA Research).
Measured: baseline, 3 and 6 months
Change in 3-day weight-bearing physical activity records from baseline to 3 and 6 months
Weight-bearing physical activity will be assessed using a validated questionaire and compared to national recommendations (frequency and duration).
Measured: baseline, 3 and 6 months
Change in sunlight exposure from baseline to 3 and 6 months
A validated sunlight exposure questionnaire will be completed to identify potential for cutaneous vitamin D synthesis based on participants' sun exposure practices.
Measured: baseline, 3 and 6 months
Change in routine clinical laboratory variables from baseline to 3 and 6 months
Routine routine clinical blood work will be assessed for changes following supplementation and for safety. Routine clinical laboratory variables to be collected include: glomerular filtration rate (GFR), urea, creatinine, hemoglobin A1c, fasting blood glucose, albumin, phosphorus, magnesium, and calcium (bound and ionized).
Measured: baseline, 3 and 6 months
Change in bone health from baseline to 3 and 6 months
Bone mineral density (BMD): Dual-energy x-ray absorptiometry (DXA; gold standard)scan conducted at baseline to characterize bone health.
Bone turnover markers: Changes in markers of bone formation (osteocalcin and bone specific alkaline phosphatase) and bone resorption (N-telopeptide of type 1 collagen and fibroblast growth factor-23) between baseline and 6 months.
Serum parathyroid hormone (PTH): Changes in serum PTH will be measured at baseline, 3 and 6 months.
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sub-optimal Vitamin D StatusStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dmager, University of Alberta
- Investigators
- Diana R Mager, PhD RD, Principal investigator, University of AlbertaPeter A Senior, MBBS PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476501
- Sponsor's protocol ID
- diabetes vitamin D 20112012
- Status last verified
- Aug 2022
- First submitted
- 15 Nov 2011
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mager DR, Jackson ST, Hoffmann MR, Jindal K, Senior PA. "Vitamin D supplementation and bone health in adults with diabetic nephropathy: the protocol for a randomized controlled trial". BMC Endocr Disord. 2014 Aug 12;14:66. doi: 10.1186/1472-6823-14-66.
PubMed 25115438Mager DR, Jackson ST, Hoffmann MR, Jindal K, Senior PA. Vitamin D3 supplementation, bone health and quality of life in adults with diabetes and chronic kidney disease: Results of an open label randomized clinical trial. Clin Nutr. 2017 Jun;36(3):686-696. doi: 10.1016/j.clnu.2016.05.012. Epub 2016 Jun 2.
PubMed 27302208
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation and Bone Health in Adults With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01476501
- Acronym / sponsor ID
- diabetes vitamin D 20112012
- Keywords
- vitamin D, bone health, diabetes, nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Nov 2011 (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.
Diabetes is a life-long disease that is getting more common in Canada. One of the most common problems in people with kidney disease is diabetes and low bone mineral density (BMD). This can lead to a higher chance for broken bones, infection and life-long health problems. The most common reason for having low BMD is not getting enough vitamin D (Vit D) in your diet and not having enough sunlight. This is very common in Canada (especially in northern Alberta) because winter is very long. Most people also don't eat or drink enough foods that are high in Vit D (like milk) and so they don't have enough Vit D in their body to make healthy bones. This can mean the only way to get enough Vit D in your body for your bones when you have kidney disease is to take some extra vitamin D in a pill. Most people are not aware that they have poor bone health until they break a bone. Broken bones can really hurt and can prevent a person from being able to walk and take care of themselves. Right now, we are not sure exactly how much Vit D people with diabetes and kidney disease need to take to prevent them from having low BMD or how often they need to take it. Our plan is to study the effect of two ways to take Vit D pills (every day or once a month) on overall Vit D status and on bone health in adult patients with diabetes and chronic kidney disease and see how this influences their quality of life.
Hypotheses:
- Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result in significantly improved overall vitamin D status and improved markers of bone health in adult patients with diabetic nephropathy.
- Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved patient adherence and satisfaction with vitamin D supplementation when compared to daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health parameters, which will result in an increased quality of life and sense of well-being.
Detailed description
Abstract:
Vitamin D has a well-established role in bone health and the prevention of fractures which are associated with increased morbidity and mortality, and reduced quality of life. However, many individuals have sub-optimal vitamin D status (<75nmol/l), and risk increases with geographical location, age, ethnicity, inadequate dietary intake and disease. Diabetes and kidney disease are two chronic diseases associated with both poor bone health and suboptimal vitamin D status. Individuals with diabetes and chronic kidney disease who live in northern Alberta are at a particular risk for suboptimal vitamin D status and poor bone health due to dietary restrictions on vitamin D rich foods (e.g. milk products that are also high in phosphorus and carbohydrates), negligible cutaneous synthesis during the long winter months, and reduced renal capacity to synthesize active vitamin D (1,25(OH)2D). In the general Canadian population, few are able to meet dietary recommendations for vitamin D intake through diet alone and often rely on vitamin D supplements. The need for vitamin D supplementation is increased in diabetics with nephropathy, however the optimal dose and strategy for vitamin D supplementation is unknown. Like other chronic diseases, adherence to therapy is a major issue in this population. With each additional chronic disease an individual has, their adherence to therapy and quality of life decreases. Adherence to vitamin D therapy is known to be particularly poor. This may be related to the silent nature of bone disease, as poor bone health is often not identified until a fracture has occurred. Novel strategies to vitamin D supplementation are needed to prevent poor bone health and fractures, and the resulting decline in quality of life that ensues. Therefore it is important to identify a vitamin D supplementation strategy that increases adherence to vitamin D supplementation and improves vitamin D status and bone health in adults with diabetes and nephropathy.
Objectives:
- Examine the impact of two approaches to oral high dose vitamin D supplementation (2,000 IU/day versus 40,000 IU/month for six months) on overall vitamin D status and markers of bone turnover in adult patients with diabetic nephropathy.
- Examine daily versus monthly vitamin D supplementation strategies in regards to adherence, satisfaction and quality of life in adult patients with diabetic nephropathy.
Hypotheses:
- Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result in significantly improved overall vitamin D status and improved markers of bone health in adult patients with diabetic nephropathy.
- Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved patient adherence and satisfaction with vitamin D supplementation when compared to daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health parameters, which will result in an increased quality of life and sense of well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2,000 IU/day vitamin D | Experimental | Drug: Vitamin D32,000 IU/day vitamin D for 6 months (n=60). |
| 40,000 IU/month vitamin D | Experimental | Drug: Vitamin D340,000 IU/month for 6 months (n=60). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnoses of diabetes (type 1 or 2) and stage 2-4 chronic kidney disease (glomerular filtration rate: 15-89 ml/min/1.73m2)
Key exclusion criteria (5 listed)
- Patients with co-morbid conditions known to affect vitamin D metabolism including gastrointestinal, liver, rheumatoid or bone disorders (e.g. hyperthyroidism, untreated celiac disease, cancer, Paget's disease, sarcoidosis, malabsorption, etc). Individuals with severe, permanent vision impairment will be excluded as this will preclude them from reading supplement labels accurately and safely. Pregnant women will be excluded as DXA scans are not recommended during pregnancy. Patients weighing >136kg will be excluded as the DXA table cannot accommodate this weight.
- Patients on drug therapy known to interfere with vitamin D (e.g. oral glucocorticoids, cholestyramine, colestipol, mineral oil, Orlistat, digoxin, antacids).
- Patients with stage 5 CKD (GFR <15ml/min/1.73m2), receiving dialysis or on kidney transplant list.
- Patients with pre-existing hypercalcemia (>2.75mmol/l), hyperphosphatemia (>2.0mmol/l), severe hyperparathyroidism (PTH >600pg/ml), and serum 25(OH)D >200nmol/l.
- Patients with serum 25(OH)D <37.5nmol/l at time of study entry/screening to control for correction of vitamin D deficiency.
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: Daily: Jamieson NPN 80017530, Monthly: EURO-Pharm DIN 02253178Randomized into 1 of 2 oral vitamin D3 softgel capsule supplementation strategies: 1) 2,000 IU/day (2 x 1,000IU/capsule each day) or 2) 40,000 IU/month (4 x 10,000IU/capsule last day of each month), for 6 months each. | Drug | 2,000 IU/day vitamin D, 40,000 IU/month vitamin D |
Primary outcome
Change in serum vitamin D from baseline to 3 and 6 months
Time frame: Change from baseline to 3 and 6 months
Changes in serum 25(OH)D and 1,25(OH)D between baseline, 3 and 6 months between individuals and between study arms.
7 secondary outcomes
Change in adherence to supplement between 3 and 6 months
Time frame: 3 and 6 months
Change in health related quality of life from baseline to 6 months
Time frame: baseline and 6 months
Change in dietary intake from baseline to 3 and 6 months
Time frame: baseline, 3 and 6 months
Change in 3-day weight-bearing physical activity records from baseline to 3 and 6 months
Time frame: baseline, 3 and 6 months
Change in sunlight exposure from baseline to 3 and 6 months
Time frame: baseline, 3 and 6 months
Change in routine clinical laboratory variables from baseline to 3 and 6 months
Time frame: baseline, 3 and 6 months
Change in bone health from baseline to 3 and 6 months
Time frame: Baseline, 3 and 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 31 Aug 2022.
- Background: PubMed 25115438Mager DR, Jackson ST, Hoffmann MR, Jindal K, Senior PA. "Vitamin D supplementation and bone health in adults with diabetic nephropathy: the protocol for a randomized controlled trial". BMC Endocr Disord. 2014 Aug 12;14:66. doi: 10.1186/1472-6823-14-66.
- Results publication: PubMed 27302208Mager DR, Jackson ST, Hoffmann MR, Jindal K, Senior PA. Vitamin D3 supplementation, bone health and quality of life in adults with diabetes and chronic kidney disease: Results of an open label randomized clinical trial. Clin Nutr. 2017 Jun;36(3):686-696. doi: 10.1016/j.clnu.2016.05.012. Epub 2016 Jun 2.
- Individual participant dataSharing planned: No
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.
Diana R Mager, PhD RD principal investigator
University of Alberta
Peter A Senior, MBBS PhD principal investigator
University of Alberta
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 Vitamin D3 in people with Sub-optimal Vitamin D Status and Bone Disease, run by University of Alberta at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 31 Aug 2022. 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 Canada. 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?
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 serum vitamin D from baseline to 3 and 6 months (time frame: Change from baseline to 3 and 6 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 NCT01476501, which also lists 2 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 31 Aug 2022.