Vitamin D Supplementation in Diabetic Nephropathy

NCT01476501 | Completed Phase 2 DMC

• 1 other identifier: diabetes vitamin D 20112012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

vitamin D; bone health; diabetes; nephropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to 3 and 6 months

Secondary Outcomes (7)

• Change in adherence to supplement between 3 and 6 months

  3 and 6 months

• Change in health related quality of life from baseline to 6 months

  baseline and 6 months

• Change in dietary intake from baseline to 3 and 6 months

  baseline, 3 and 6 months

• Change in 3-day weight-bearing physical activity records from baseline to 3 and 6 months

  baseline, 3 and 6 months

• Change in sunlight exposure from baseline to 3 and 6 months

  baseline, 3 and 6 months

Study Arms (2)

2,000 IU/day vitamin D

EXPERIMENTAL

2,000 IU/day vitamin D for 6 months (n=60).

Drug: Vitamin D3

40,000 IU/month vitamin D

EXPERIMENTAL

40,000 IU/month for 6 months (n=60).

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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.

Also known as: Daily: Jamieson NPN 80017530, Monthly: EURO-Pharm DIN 02253178

2,000 IU/day vitamin D; 40,000 IU/month vitamin D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnoses of diabetes (type 1 or 2) and stage 2-4 chronic kidney disease (glomerular filtration rate: 15-89 ml/min/1.73m2)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Clinical Research Unit, University of Alberta

Edmonton, Alberta, T6G 0K2, Canada

Location

Related Publications (2)

• 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.

  PMID: 25115438 BACKGROUND

• Mager 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.

  PMID: 27302208 RESULT

MeSH Terms

Conditions

Bone Diseases; Diabetic Nephropathies; Diabetes Mellitus; Kidney Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Diana R Mager, PhD RD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Peter A Senior, MBBS PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)