New Biomarkers for Measuring Vitamin D LevelNCT02969850
A New Paradigm for Vitamin D Sufficiency
A study testing Vitamin D Supplementation and Calcium in people with New Biomarkers for Measuring Vitamin D Level, run by NYU Langone Health at 1 site in United States.
Trial summary
Although the African-American (AA) population tends to have lower serum 25(OH)D levels compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans are harmful. In fact, skeletal health is superior in AA. Read more about this study
- Who is it for?
- Ages 60 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- New Biomarkers for Measuring Vitamin D Level
- What is being tested?
- Vitamin D Supplementation and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 1 Dec 2019
- Phase
- Interventional
- 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 60 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory women older than 60 years of age. Women who are ambulatory with an assistive device such as cane or walker may be included. LMP must be > 5 years ago.
- Self declared as white.
- 20 nmol/L < Serum 25(OH)D level < 65 nmol/L.
- Willingness to take study drug and participate for 6 months in the trial.
- Willingness to refrain from the use of self-administered Vitamin D and Calcium supplements during the trial.
Who cannot join
- Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
- BMD total hip below -2.5 standard deviation (using NHANES III adult young white men and women as the point of reference) or history of osteoporotic fracture.
- Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA.
- Treatment with HRT, SERMs, calcitonin, PTH, strontium ranelate, androgens, bisphosphonates, Denosumab or anabolic steroids during 6 months prior to entry.
- Use of systemic corticosteroids (oral or IV) within the last year at an average dose of greater than 5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.
- Mini-Mental State Exam score below 21
Show all 19Show fewer
- Hypercalcemia (serum calcium > 10.6 mg/dl) or history of primary hyperparathyroidism.
- History of hypercalciuria, kidney stones, or 24hr urine calcium >261 mg/day on screening.
- History of chronic liver disease, chronic renal insufficiency (GFR<30), Parkinson's, metabolic bone disease (Hyperparathyroidism, Hypoparathyroidism, Paget's disease, Fibrous osteodystrophy, Rickets, Osteomalacia, Osteosclerosis), hematologic tumors, rheumatologic disease requiring steroids, conditions that influence vitamin D absorption like celiac disease and irritable bowel disease, malabsorption or new diagnosis or active treatment of cancer 12 months prior to inclusion.
- Use of medications that influence bone metabolism (e.g. anticonvulsants).
- Significant deviation from normal in either: history, physical examination or laboratory tests as evaluated by the Principle Investigator. Participants with a history of uncontrolled hypertension, uncontrolled diabetes, hypercalciuria, nephrolithiasis and active sarcoidosis or tuberculosis will also be excluded.
- Participation in another investigational trial 30 days prior to screening.
- Spinal disease that affects interpretation of bone densitometry like scoliosis with a Cobb angle greater than 15o, history of surgery at lumbosacral spine.
- Bilateral hip replacement.
- Currently smoking more than 10 cigarettes daily.
- Currently consuming more than 2 units of alcohol daily. (One unit is equivalent to a standard glass of beer (285ml), a single measure of spirits (30ml), a medium-sized glass of wine (120ml), or 1 measure of an aperitif (60ml)
- Unable to perform DXA due to excessive body girth/width. Body width on DXA > 25 cm.
- Patients who are deemed unsafe to perform muscular function testing as evaluated by the investigator.
- Class III obesity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: A New Paradigm for Vitamin D Sufficiency: A 6-month, Randomized, Double-blind, Placebo-controlled Study to Investigate Vitamin D Status in Elderly Caucasian Women
Although the African-American (AA) population tends to have lower serum 25(OH)D levels compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans are harmful. In fact, skeletal health is superior in AA. It is clear that total serum 25(OH)D concentrations do not reflect the same risk/benefit ratio in AA compared to white women and is, therefore, an inappropriate biomarker in this population.
The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The investigators propose a six month randomized double blinded study.
Read the detailed description
The specific aims of this study are as follows:
- To establish that free 25(OH)D and VMR are similar in black and white populations.
- To characterize the relationships between free 25(OH)D and VMR and two measures of bone health (PTH and BMD) in black and white women.
- To evaluate whether the relationship of free 25(OH)D (and in parallel analyses, VMR) and bone health are stronger than those based on total 25(OH)D.
- To evaluate whether free 25(OH)D and VMR respond to vitamin D intake (dose-response) in a similar manner to total 25(OH)D.
The study population is postmenopausal Caucasian women age 60 and older. This six month study includes four visits. These results will be compared to those from a study in AA women which the investigators are also completing.
There are two study groups. One group will receive vitamin D supplementation, the other a placebo. Subjects will be asked to refrain from taking outside Vitamin D supplements for the duration of the study. If the subject is eligible based on the results from the first two visits, the subject will be randomized into one of these two groups. Randomized subjects will be taking the vitamin D or placebo for a period of 6 months and will have one visit at the 3 month mark and a final visit at the 6 month mark.
At the 3-month visit, the following procedures will be conducted: obtain interim medical and travel history, vital signs, weight, and height measured by the Harpenden Stadiometer, record adverse events and concomitant medications, Fasting blood collection: total 25(OH)D (by Diasorin), PTH, serum calcium and creatinine, Fasting urine collection for calcium and creatinine, and questionnaires: calcium food frequency questionnaire, quality of life questionnaire, falls and flu questionnaires. Subjects will be instructed on how to collect a 24-hour urine sample (for final visit) and collection container will be dispensed. Unused study supplements will be collected and counted, and study supplements will be dispensed based on serum 25(OH)D level algorithm.
At the 6-month visit, in addition to what is completed at the 3-month visit, the following procedures will also be conducted:24-hour urine calcium, sodium, oxalate and creatinine; mini-mental health examination; physical performance examination (SPPB); and a physical activity questionnaire. Unused study supplements will be collected and counted. No further supplementation will be provided.
- Being tested
- Vitamin D Supplementation, Placebo, Calcium
- Keywords
- vitamin D supplementation, calcium supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D SupplementationDietary supplement
Subjects in this group will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level.
PlaceboOther
Subjects in this group will receive a placebo.
CalciumDietary supplement
If dietary calcium intake is insufficient in participants of either group, they will be given a calcium supplement in the form of one 600mg pill of CaCO3 to bring them up to an intake of 1200mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Supplementation | Experimental | Participant will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day. Receives: Dietary Supplement: Vitamin D Supplementation; Dietary Supplement: Calcium |
| Placebo | Placebo comparator | Participant will receive a placebo. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day. Receives: Other: Placebo; Dietary Supplement: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare free 25(OH)D levels in Caucasian women (current study) and AA women (from prior study)
VDBP will be measured and free 25(OH)D calculated
Measured: baseline
Compare Vitamin D metabolite ratio (VMR) in Caucasian women (current study) and AA women (from prior study)
serum 24,25(OH)2D and serum 25(OH)D will be measured and VMR calculated
Measured: baseline
Secondary outcomes (3)
Relationship between free 25(OH)D and two measures of bone health (PTH and BMD)
Relationships will be assessed via correlation and regression analyses
Measured: baseline
Relationship between VMR and two measures of bone health (PTH and BMD)
Relationships will be assessed via correlation and regression analyses
Measured: baseline
Relationship between vitamin D intake and Change in Physical Performance Assessment (SPPB)
Relationships will be assessed via Mixed-Effects Model for Repeated Measures (MMRM)
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Biomarkers for Measuring Vitamin D LevelStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Winthrop University Hospital
- Responsible party
- Sponsor
- Investigators
- John Aloia, MD, Principal investigator, Winthrop University HospitalMageda Mikhail, MD, Study director, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969850
- Sponsor's protocol ID
- 19-00873
- Status last verified
- Oct 2021
- First submitted
- 10 Nov 2016
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Paradigm for Vitamin D Sufficiency: A 6-month, Randomized, Double-blind, Placebo-controlled Study to Investigate Vitamin D Status in Elderly Caucasian Women
- ClinicalTrials.gov ID
- NCT02969850
- Acronym / sponsor ID
- 19-00873
- Keywords
- vitamin D supplementation, calcium supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Winthrop University Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 21 Nov 2016 (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.
Although the African-American (AA) population tends to have lower serum 25(OH)D levels compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans are harmful. In fact, skeletal health is superior in AA. It is clear that total serum 25(OH)D concentrations do not reflect the same risk/benefit ratio in AA compared to white women and is, therefore, an inappropriate biomarker in this population.
The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The investigators propose a six month randomized double blinded study.
Detailed description
The specific aims of this study are as follows:
- To establish that free 25(OH)D and VMR are similar in black and white populations.
- To characterize the relationships between free 25(OH)D and VMR and two measures of bone health (PTH and BMD) in black and white women.
- To evaluate whether the relationship of free 25(OH)D (and in parallel analyses, VMR) and bone health are stronger than those based on total 25(OH)D.
- To evaluate whether free 25(OH)D and VMR respond to vitamin D intake (dose-response) in a similar manner to total 25(OH)D.
The study population is postmenopausal Caucasian women age 60 and older. This six month study includes four visits. These results will be compared to those from a study in AA women which the investigators are also completing.
There are two study groups. One group will receive vitamin D supplementation, the other a placebo. Subjects will be asked to refrain from taking outside Vitamin D supplements for the duration of the study. If the subject is eligible based on the results from the first two visits, the subject will be randomized into one of these two groups. Randomized subjects will be taking the vitamin D or placebo for a period of 6 months and will have one visit at the 3 month mark and a final visit at the 6 month mark.
At the 3-month visit, the following procedures will be conducted: obtain interim medical and travel history, vital signs, weight, and height measured by the Harpenden Stadiometer, record adverse events and concomitant medications, Fasting blood collection: total 25(OH)D (by Diasorin), PTH, serum calcium and creatinine, Fasting urine collection for calcium and creatinine, and questionnaires: calcium food frequency questionnaire, quality of life questionnaire, falls and flu questionnaires. Subjects will be instructed on how to collect a 24-hour urine sample (for final visit) and collection container will be dispensed. Unused study supplements will be collected and counted, and study supplements will be dispensed based on serum 25(OH)D level algorithm.
At the 6-month visit, in addition to what is completed at the 3-month visit, the following procedures will also be conducted:24-hour urine calcium, sodium, oxalate and creatinine; mini-mental health examination; physical performance examination (SPPB); and a physical activity questionnaire. Unused study supplements will be collected and counted. No further supplementation will be provided.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Supplementation | Experimental | Dietary Supplement: Vitamin D Supplementation, Dietary Supplement: CalciumParticipant will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day. |
| Placebo | Placebo comparator | Other: Placebo, Dietary Supplement: CalciumParticipant will receive a placebo. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatory women older than 60 years of age. Women who are ambulatory with an assistive device such as cane or walker may be included. LMP must be > 5 years ago.
- Self declared as white.
- 20 nmol/L < Serum 25(OH)D level < 65 nmol/L.
- Willingness to take study drug and participate for 6 months in the trial.
- Willingness to refrain from the use of self-administered Vitamin D and Calcium supplements during the trial.
Key exclusion criteria (19 listed)
- Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
- BMD total hip below -2.5 standard deviation (using NHANES III adult young white men and women as the point of reference) or history of osteoporotic fracture.
- Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA.
- Treatment with HRT, SERMs, calcitonin, PTH, strontium ranelate, androgens, bisphosphonates, Denosumab or anabolic steroids during 6 months prior to entry.
- Use of systemic corticosteroids (oral or IV) within the last year at an average dose of greater than 5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.
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 |
|---|---|---|
| Vitamin D SupplementationSubjects in this group will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level. | Dietary supplement | Vitamin D Supplementation |
| PlaceboSubjects in this group will receive a placebo. | Other | Placebo |
| CalciumIf dietary calcium intake is insufficient in participants of either group, they will be given a calcium supplement in the form of one 600mg pill of CaCO3 to bring them up to an intake of 1200mg/day. | Dietary supplement | Placebo, Vitamin D Supplementation |
Primary outcome
Compare free 25(OH)D levels in Caucasian women (current study) and AA women (from prior study)
Time frame: baseline
VDBP will be measured and free 25(OH)D calculated
Compare Vitamin D metabolite ratio (VMR) in Caucasian women (current study) and AA women (from prior study)
Time frame: baseline
serum 24,25(OH)2D and serum 25(OH)D will be measured and VMR calculated
3 secondary outcomes
Relationship between free 25(OH)D and two measures of bone health (PTH and BMD)
Time frame: baseline
Relationship between VMR and two measures of bone health (PTH and BMD)
Time frame: baseline
Relationship between vitamin D intake and Change in Physical Performance Assessment (SPPB)
Time frame: baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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.
John Aloia, MD principal investigator
Winthrop University Hospital
Mageda Mikhail, MD study director
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D Supplementation and Calcium in people with New Biomarkers for Measuring Vitamin D Level, run by NYU Langone Health at 1 site in United States.
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 5 inclusion and 19 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: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare free 25(OH)D levels in Caucasian women (current study) and AA women (from prior study) (time frame: baseline). The study lists 2 primary outcomes in all. 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 22 Oct 2021.