Vitamin D Supplementation in Diabetic Nephropathy
Condition: Sub-optimal Vitamin D Status; Bone Disease; Diabetic Nephropathy
MeSH terms: Bone Diseases; Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

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. 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:

        1. 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.

        2. 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:

        1. 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.

        2. 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.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Daily: Jamieson NPN 80017530; Monthly: EURO-Pharm DIN 02253178
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin D; bone health; diabetes; nephropathy