Vitamin D 2 to Dialysis Patients

Pain Clinical Trial

— D2D  

Official title:

Vitamin D and Muscle Strength in the Dialysis Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00535158
• Other study ID #: 2007p-000613
• Status: Terminated
• Phase: N/A
• First received: September 24, 2007
• Last updated: March 14, 2017
• Start date: June 1, 2008
• Est. completion date: June 1, 2009

Study information

• Verified date: March 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 1, 2009
• Est. primary completion date: June 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Kidney Disease
• Kidney Diseases
• Muscle Weakness
• Pain
• Paresis

Intervention

Drug:
• Ergocalciferol (Vitamin D 2)
50,000units once weekly for 8 weeks then every other week for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D 2 levels of Dialysis Patients		1 year
Secondary	Muscle strength	timed up and go test and dynamometry of four different muscle groups	1 year