Vitamin D 2 to Dialysis Patients (D2D)

March 14, 2017 updated by: Ajay K. Singh, Brigham and Women's Hospital

Vitamin D and Muscle Strength in the Dialysis Population

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic hemodialysis patients

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Vitamin D 2 levels of Dialysis Patients
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 1 year
timed up and go test and dynamometry of four different muscle groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ajay K Singh, M.D., Brigham and Womens Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007p-000613

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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