Vitamin D 2 to Dialysis Patients (D2D)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00535158
First received: September 24, 2007
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Kidney Disease
Muscle Weakness
Pain
Fractures, Bone
Drug: Ergocalciferol (Vitamin D 2)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Vitamin D and Muscle Strength in the Dialysis Population

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • We hypothesize that a large proportion of the study population will be 25-hydroxyvitamin D insufficient (< 25ng/ml), and performance on the muscle function tests will correlate with 25OHD levels.

Secondary Outcome Measures:
  • We expect a 25% improvement in mean TUG values at twelve weeks in the treatment group when compared to the placebo group.

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ergocalciferol (Vitamin D 2)
    50,000units once weekly for 8 weeks then every other week for 4 weeks
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535158

Contacts
Contact: Susana L Dipp, M.D. 617-525-8285 sdipp@partners.org
Contact: Paula M Hertello 617-525-7817 phertelo@partners.org

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Ajay K Singh, M.D. Brigham and Womens Hospital
  More Information

No publications provided

Responsible Party: Ajay K Singh, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00535158     History of Changes
Other Study ID Numbers: 2007p-000613
Study First Received: September 24, 2007
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Chronic Kidney disease
Dialysis
Vitamin D
Chronic kidney disease is associated with impaired muscle strength, pain and fractures.

Additional relevant MeSH terms:
Asthenia
Fractures, Bone
Kidney Diseases
Muscle Weakness
Paresis
Signs and Symptoms
Wounds and Injuries
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014