Vitamin D Supplementation in Diabetic Nephropathy

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.

Conditions

• Sub-optimal Vitamin D Status
• Bone Disease
• Diabetic Nephropathy

Interventions

DRUG

Vitamin D3

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.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• Diana R Mager, PhD RD · University of Alberta

• Peter A Senior, MBBS PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2014-12-31

Completion

2015-12-31

Countries

• Canada

Study Locations