Vitamin D 2 to Dialysis Patients (D2D)

Vitamin D and Muscle Strength in the Dialysis Population

Vitamin D is necessary for healthy bones. Vitamin D is made in our skin when we are exposed to sunlight, but it is also found in foods that we eat and in vitamin pills. Low levels of vitamin D are common in many groups of people, because we do not get enough sun during the winter and because we eat few foods that have vitamin D in them. Some foods with vitamin D are salmon, mackerel, tuna, and fortified milk, which has had vitamin D added to it.

We know that nearly all kidney disease patients on dialysis do not have enough vitamin D in their bodies. We believe this condition can cause muscle weakness, leading to falls and broken bones. These are common problems for patients who are receiving dialysis. For example, dialysis patients have a much higher risk of hip fractures (broken hips). However, no formal research has been done on patients with low vitamin D levels receiving dialysis, to see if they actually have muscle weakness and related problems.

There are two goals of this study. First, we want to see if patients on dialysis who have low vitamin D levels are actually at risk for muscle weakness, muscle pain, and broken bones. We also want to find out if giving vitamin D pills to these patients will result in better muscle strength, less muscle pain, and fewer falls.

In this study, we will compare vitamin D to placebo. Placebo capsules look exactly like vitamin D capsules but contain no active ingredients. We use placebos in research studies to be sure that the study results are due to the study drug and not to other reasons.

Study Overview

• Status: Terminated
• Conditions: Pain; Fractures, Bone; Muscle Weakness; Kidney Disease
• Intervention / Treatment: Drug: Ergocalciferol (Vitamin D 2)

Detailed Description

Inclusion criteria:

Age ³ 18, CKD on hemodialysis, men and women, hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl, no recent (in the last three months) admissions to the hospital, ability to walk ten feet with or without a walking aid.

Exclusion criteria:

Subjects who are pregnant or lactating; subjects with history of kidney stones, malabsorption syndromes, tertiary hyperparathyroidism defined by a parathyroid hormone of >500pg/ml, current use of corticosteroids, non-ambulatory subjects (for example paraplegic subjects), serious fracture in the last three months, and corrected calcium levels of 10.5 mg/dl or greater.

• Study Type: Observational
• Enrollment (Actual): 18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic hemodialysis patients

Description

Inclusion criteria:

• Age ³ 18
• CKD on hemodialysis
• Men and women
• Hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl,
• No recent (in the last three months) admissions to the hospital
• Ability to walk ten feet with or without a walking aid.

Exclusion criteria:

• Subjects who are pregnant or lactating
• Subjects with history of kidney stones
• Malabsorption syndromes
• Tertiary hyperparathyroidism defined by a parathyroid hormone of >500pg/ml, current use of corticosteroids
• Non-ambulatory subjects (for example paraplegic subjects)
• Serious fracture in the last three months, and
• Corrected calcium levels of 10.5 mg/dl or greater.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vitamin D 2 levels of Dialysis Patients	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	timed up and go test and dynamometry of four different muscle groups	1 year

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Ajay K Singh, M.D., Brigham and Womens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: September 24, 2007
• First Submitted That Met QC Criteria: September 25, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D; Dialysis; Chronic Kidney disease; Chronic kidney disease is associated with impaired muscle strength, pain and fractures.
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Kidney Diseases; Muscle Weakness; Fractures, Bone; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: 2007p-000613