Vitamin D 2 to Dialysis Patients

NCT ID: NCT00535158

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-01
• Study Completion Date: 2009-06-01

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.

Conditions

Kidney Disease; Muscle Weakness; Pain; Fractures, Bone

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Ergocalciferol (Vitamin D 2)

50,000units once weekly for 8 weeks then every other week for 4 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ajay K. Singh

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajay K Singh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Womens Hospital

Other Identifiers

2007p-000613

Identifier Type: -

Identifier Source: org_study_id