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Vitamin D 2 to Dialysis Patients (D2D)

This study has been terminated.
(Because of departure of study personnel and lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00535158
First Posted: September 26, 2007
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ajay K. Singh, Brigham and Women's Hospital
  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
Kidney Disease Muscle Weakness Pain Fractures, Bone Drug: Ergocalciferol (Vitamin D 2)

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Vitamin D and Muscle Strength in the Dialysis Population

Resource links provided by NLM:


Further study details as provided by Ajay K. Singh, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Vitamin D 2 levels of Dialysis Patients [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Muscle strength [ Time Frame: 1 year ]
    timed up and go test and dynamometry of four different muscle groups


Enrollment: 18
Actual Study Start Date: June 1, 2008
Study Completion Date: June 1, 2009
Primary Completion Date: June 1, 2009 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic hemodialysis patients
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535158


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

Responsible Party: Ajay K. Singh, Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00535158     History of Changes
Other Study ID Numbers: 2007p-000613
First Submitted: September 24, 2007
First Posted: September 26, 2007
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Ajay K. Singh, 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:
Kidney Diseases
Muscle Weakness
Paresis
Fractures, Bone
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Wounds and Injuries
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents