Kidney DiseaseD2DNCT00535158
Vitamin D 2 to Dialysis Patients
An observational study of Kidney Disease and Muscle Weakness, run by Brigham and Women's Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Muscle Weakness, Pain
- What is being tested?
- Ergocalciferol (Vitamin D 2)
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2008to 1 Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic hemodialysis patients
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Ergocalciferol (Vitamin D 2)
- Keywords
- Chronic Kidney disease, Dialysis, Vitamin D, Chronic kidney disease is associated with impaired muscle strength, pain and fractures.
- Medical subject headings
- Kidney Diseases, Muscle Weakness, Pain, Fractures, Bone, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol (Vitamin D 2)Drug
50,000units once weekly for 8 weeks then every other week for 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D 2 levels of Dialysis Patients
Measured: 1 year
Secondary outcomes (1)
Muscle strength
timed up and go test and dynamometry of four different muscle groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study start1 Jun 2008
- Primary completion1 Jun 2009
- Study completion1 Jun 2009
Why it stopped: Because of departure of study personnel and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay K. Singh, Brigham and Women's Hospital
- Investigators
- Ajay K Singh, M.D., Principal investigator, Brigham and Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535158
- Sponsor's protocol ID
- 2007p-000613
- Acronym
- D2D
- Status last verified
- Mar 2017
- First submitted
- 24 Sep 2007
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Muscle Strength in the Dialysis Population
- ClinicalTrials.gov ID
- NCT00535158
- Acronym / sponsor ID
- D2D / 2007p-000613
- 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.
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Because of departure of study personnel and lack of funding
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 1 Jun 2009 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hemodialysis patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergocalciferol (Vitamin D 2)50,000units once weekly for 8 weeks then every other week for 4 weeks | Drug | – |
Primary outcome
Vitamin D 2 levels of Dialysis Patients
Time frame: 1 year
1 secondary outcome
Muscle strength
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Because of departure of study personnel and lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
Related trials for Kidney Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay K Singh, M.D. principal investigator
Brigham and Womens Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease and Muscle Weakness, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because of departure of study personnel and lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D 2 levels of Dialysis Patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.