Clinical trial NCT00535158: Vitamin D 2 to Dialysis Patients
Official title: Vitamin D and Muscle Strength in the Dialysis Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Disease
Muscle Weakness
Pain
Fractures, Bone
Keywords: Chronic Kidney disease
Dialysis
Vitamin D
Chronic kidney disease is associated with impaired muscle strength, pain and fractures.
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hemodialysis patients

Brief summary: 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.

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 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.

Primary outcomes:
measure: Vitamin D 2 levels of Dialysis Patients
timeFrame: 1 year
Secondary outcomes:
measure: Muscle strength
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Womens Hospital
name: Ajay K Singh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: