Delusion of ReferenceNCT02019381
Study the Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism.
A study testing Endocrine Society UL Dosage Vitamin D, Institute of Medicine Dosage Vitamin D and Calcium in people with Delusion of Reference, run by Winthrop University Hospital at 1 site in United States.
Trial summary
Recently two distinguished committees, Institute of Medicine (IOM) and The Endocrine Society have proposed different intake guidelines for Calcium and Vitamin D. We wish to compare the effects of both of them on calcium metabolism and bone turnover. We propose a one year randomized double blinded study for the same. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delusion of Reference
- What is being tested?
- Endocrine Society UL Dosage Vitamin D, Institute of Medicine Dosage Vitamin D and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2016
- 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 50 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy White women aged 50 and older who have been postmenopausal for at least 2 year (i.e. absence of menstrual period for a period of 24 months or more).
- Willingness to discontinue self-administration of vitamin D and calcium supplements. Participants must be at least three months off supplements before starting the study.
- Willingness to take study medications and participate in study for one year.
- Written informed Consent Signed.
- Patients with hypertension and diabetes stable for last three months.
Who cannot join
- History of hypercalciuria (24-hour urinary calcium excretion >250 mg), hypercalcemia (serum calcium >10.6), nephrolithiasis and active sarcoidosis will be excluded.
- Serum 25-hydroxyvitamin D level >80 nmol/L or history of primary hyperparathyroidism.
- Dietary calcium intake of >2000mg/day will be excluded
- Use of medication that influences bone or vitamin D metabolism (e.g. anticonvulsant medications, glucocorticoids, Highly Active AntiRetroviral Therapy [AIDS treatment], antirejection medications, chronic use of steroids, high dose diuretics)
- Treatment with Hormone replacement therapy, Selective Estrogen Receptor Modulators, Calcitonin, Parathyroid hormone , androgens, bisphosphonates, phosphate or anabolic steroids 6 months prior to the study.
- Use of systemic steroids (oral or intravenous) within the last year at an average dose of more than 5mg/day of oral prednisone or an equivalent for a period of three months or more prior to screening.
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- Chronic medical illness including Chronic liver disease, uncontrolled diabetes mellitus; recent history of myocardial infarction or heart failure; newly diagnosed or active malignancy; uncontrolled hypertension; obesity (BMI>35 kg/m2); malabsorption, anemia, leukemia, or other hematologic abnormalities; lupus, rheumatoid arthritis, sarcoidosis, or other rheumatologic disease; chronic kidney disease, metabolic bone disease.
- Unexplained weight loss of >15% during the previous year or history of anorexia nervosa
- > 1 pack per day tobacco use or > 2 alcoholic beverages per day
- Unwillingness to forego self-administration of vitamin D and calcium-containing supplements.
- Participation in another investigational trial in the past 30 days prior to the screening evaluation
- Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator.
- Patients with unstable hypertension or diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: The Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism in Postmenopausal White Women.
Recently two distinguished committees, Institute of Medicine (IOM) and The Endocrine Society have proposed different intake guidelines for Calcium and Vitamin D. We wish to compare the effects of both of them on calcium metabolism and bone turnover. We propose a one year randomized double blinded study for the same.
Read the detailed description
The specific aims of this study proposal are to determine the following:
- To compare the two different intake guidelines for Calcium and Vitamin D Supplementation at its recommended tolerable upper limit on serum and urinary calcium in white postmenopausal Women.
- Compare the effects above mentioned two intake guidelines on Vitamin D metabolism [25(OH)D, 1,25(OH)2D] and bone turnover.
Participants will be randomly assigned to Group A or Group B based on different dosages of study medications.
Group A: 10,000 IU (International Units)Vitamin D + Placebo (sugar pill) 600IU Vitamin D + Two pills Calcium containing 600mg calcium each.
Group B: 600 IU Vitamin D + Placebo (sugar pill) 10,000 IU Vitamin D
+ Two pills Calcium containing 600mg calcium each.
In addition to the calcium supplements, they will guide to include approximately 800mg of calcium in their daily diet.
At visit 2, fasting blood and spot urine will be collected. A urinal will be dispensed for collection of 24-hour urine for urinary calcium to be brought in next day. Study medication will be dispensed and participants will be asked not to discard unused medications and to bring all study medications next study visit.
Visit 3, 4, 5, 6 will essentially be the same as visit 2, with subjects returning unused study medication and given new tablets each visit. Except on visit 6 no further study medications will be dispensed, after collecting the previous supply.
Food frequency questionnaires will be filled out at the initial visit and final visit. Diet will be assessed using 3-day diet history form and Nutrition Pro analysis software. Patients will be asked to refrain from taking other Vitamin D supplements and to continue their usual calcium intake.
- Conditions
- Delusion of Reference
- Being tested
- Endocrine Society UL Dosage Vitamin D, Institute of Medicine Dosage Vitamin D, Calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine Society UL Dosage Vitamin DDietary supplement
Endocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium
Institute of Medicine Dosage Vitamin DDietary supplement
IOM arm will get 600 IU Vitamin D and 1,200 mg Calcium
CalciumDietary supplement
1200mg of CaCO3 supplementation will be given to each participant in both groups
| Study group | Role | What they receive |
|---|---|---|
| Endocrine Society UL Dosage Vitamin D | Other | Participants will be randomly assigned vitamin D + calcium dose based on Endocrine Society Upper limit guidelines. And given 10,000IU Vitamin D + 1200mg Calcium (600IU Placebo Vitamin D, in addition to two calcium tablets of 600mg) each to be taken per day. Receives: Dietary Supplement: Endocrine Society UL Dosage Vitamin D; Dietary Supplement: Calcium |
| Institute of Medicine Dosage Vitamin D | Other | Participants will be randomly assigned Vitamin D dose based on IOM guidelines; calcium dose will be as per IOM upper limits. And will receive 600 IU Vitamin D + 1,200 mg of calcium tablets to be taken per day. Receives: Dietary Supplement: Institute of Medicine Dosage Vitamin D; Dietary Supplement: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effects of 10000 IU/day vitamin D plus 2,000 mg/day calcium versus 600 IU/day vitamin D plus 2,000 mg/day calcium on incidence of hypercalciuria (spot urine calcium:creatinine ratio, 24-hour urine calcium).
Endocrine society has recommended tolerable upper limit or a dose with no adverse events as 10,000IU of Vitamin D and 2000 mg/day of calcium. Our study will test the safety/ efficacy of this recommendation.
Measured: One year
Secondary outcomes (1)
Compare the effects of 10,000 IU/day vitamin D plus 2,000 mg/day calcium versus 600 IU/day vitamin D plus 2,000 mg/day calcium on vitamin D metabolism [25(OH)D, 1,25(OH)2D], and bone turnover.
To test safety/efficacy of The Endocrine Society recommendations on Bone turnover.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delusion of ReferenceStudies of the same condition, open and under way.
- 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John F. Aloia, MD, Winthrop University Hospital
- Investigators
- John Aloia, MD, Principal investigator, Winthrop UHMageda Mikhail, MD, Study director, Winthrop UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019381
- Sponsor's protocol ID
- 13005
- Status last verified
- Dec 2016
- First submitted
- 12 Sep 2013
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Aloia JF, Katumuluwa S, Stolberg A, Usera G, Mikhail M, Hoofnagle AN, Islam S. Safety of calcium and vitamin D supplements, a randomized controlled trial. Clin Endocrinol (Oxf). 2018 Dec;89(6):742-749. doi: 10.1111/cen.13848. Epub 2018 Oct 1.
PubMed 30180273
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism in Postmenopausal White Women.
- ClinicalTrials.gov ID
- NCT02019381
- Acronym / sponsor ID
- 13005
- Conditions
- Delusion of Reference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Dec 2013 (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.
Recently two distinguished committees, Institute of Medicine (IOM) and The Endocrine Society have proposed different intake guidelines for Calcium and Vitamin D. We wish to compare the effects of both of them on calcium metabolism and bone turnover. We propose a one year randomized double blinded study for the same.
Detailed description
The specific aims of this study proposal are to determine the following:
- To compare the two different intake guidelines for Calcium and Vitamin D Supplementation at its recommended tolerable upper limit on serum and urinary calcium in white postmenopausal Women.
- Compare the effects above mentioned two intake guidelines on Vitamin D metabolism [25(OH)D, 1,25(OH)2D] and bone turnover.
Participants will be randomly assigned to Group A or Group B based on different dosages of study medications.
Group A: 10,000 IU (International Units)Vitamin D + Placebo (sugar pill) 600IU Vitamin D + Two pills Calcium containing 600mg calcium each.
Group B: 600 IU Vitamin D + Placebo (sugar pill) 10,000 IU Vitamin D
+ Two pills Calcium containing 600mg calcium each.
In addition to the calcium supplements, they will guide to include approximately 800mg of calcium in their daily diet.
At visit 2, fasting blood and spot urine will be collected. A urinal will be dispensed for collection of 24-hour urine for urinary calcium to be brought in next day. Study medication will be dispensed and participants will be asked not to discard unused medications and to bring all study medications next study visit.
Visit 3, 4, 5, 6 will essentially be the same as visit 2, with subjects returning unused study medication and given new tablets each visit. Except on visit 6 no further study medications will be dispensed, after collecting the previous supply.
Food frequency questionnaires will be filled out at the initial visit and final visit. Diet will be assessed using 3-day diet history form and Nutrition Pro analysis software. Patients will be asked to refrain from taking other Vitamin D supplements and to continue their usual calcium intake.
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 |
|---|---|---|
| Endocrine Society UL Dosage Vitamin D | Other | Dietary Supplement: Endocrine Society UL Dosage Vitamin D, Dietary Supplement: CalciumParticipants will be randomly assigned vitamin D + calcium dose based on Endocrine Society Upper limit guidelines. And given 10,000IU Vitamin D + 1200mg Calcium (600IU Placebo Vitamin D, in addition to two calcium tablets of 600mg) each to be taken per day. |
| Institute of Medicine Dosage Vitamin D | Other | Dietary Supplement: Institute of Medicine Dosage Vitamin D, Dietary Supplement: CalciumParticipants will be randomly assigned Vitamin D dose based on IOM guidelines; calcium dose will be as per IOM upper limits. And will receive 600 IU Vitamin D + 1,200 mg of calcium tablets to be taken per day. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy White women aged 50 and older who have been postmenopausal for at least 2 year (i.e. absence of menstrual period for a period of 24 months or more).
- Willingness to discontinue self-administration of vitamin D and calcium supplements. Participants must be at least three months off supplements before starting the study.
- Willingness to take study medications and participate in study for one year.
- Written informed Consent Signed.
- Patients with hypertension and diabetes stable for last three months.
Key exclusion criteria (13 listed)
- History of hypercalciuria (24-hour urinary calcium excretion >250 mg), hypercalcemia (serum calcium >10.6), nephrolithiasis and active sarcoidosis will be excluded.
- Serum 25-hydroxyvitamin D level >80 nmol/L or history of primary hyperparathyroidism.
- Dietary calcium intake of >2000mg/day will be excluded
- Use of medication that influences bone or vitamin D metabolism (e.g. anticonvulsant medications, glucocorticoids, Highly Active AntiRetroviral Therapy [AIDS treatment], antirejection medications, chronic use of steroids, high dose diuretics)
- Treatment with Hormone replacement therapy, Selective Estrogen Receptor Modulators, Calcitonin, Parathyroid hormone , androgens, bisphosphonates, phosphate or anabolic steroids 6 months prior to the study.
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 |
|---|---|---|
| Endocrine Society UL Dosage Vitamin DEndocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium | Dietary supplement | Endocrine Society UL Dosage Vitamin D |
| Institute of Medicine Dosage Vitamin DIOM arm will get 600 IU Vitamin D and 1,200 mg Calcium | Dietary supplement | Institute of Medicine Dosage Vitamin D |
| Calcium1200mg of CaCO3 supplementation will be given to each participant in both groups | Dietary supplement | Endocrine Society UL Dosage Vitamin D, Institute of Medicine Dosage Vitamin D |
Primary outcome
Compare the effects of 10000 IU/day vitamin D plus 2,000 mg/day calcium versus 600 IU/day vitamin D plus 2,000 mg/day calcium on incidence of hypercalciuria (spot urine calcium:creatinine ratio, 24-hour urine calcium).
Time frame: One year
Endocrine society has recommended tolerable upper limit or a dose with no adverse events as 10,000IU of Vitamin D and 2000 mg/day of calcium. Our study will test the safety/ efficacy of this recommendation.
1 secondary outcome
Compare the effects of 10,000 IU/day vitamin D plus 2,000 mg/day calcium versus 600 IU/day vitamin D plus 2,000 mg/day calcium on vitamin D metabolism [25(OH)D, 1,25(OH)2D], and bone turnover.
Time frame: One year
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 Dec 2016.
- Derived from this study: PubMed 30180273Aloia JF, Katumuluwa S, Stolberg A, Usera G, Mikhail M, Hoofnagle AN, Islam S. Safety of calcium and vitamin D supplements, a randomized controlled trial. Clin Endocrinol (Oxf). 2018 Dec;89(6):742-749. doi: 10.1111/cen.13848. Epub 2018 Oct 1.
- Individual participant dataSharing planned: Undecided
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 UH
Mageda Mikhail, MD study director
Winthrop UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocrine Society UL Dosage Vitamin D, Institute of Medicine Dosage Vitamin D and Calcium in people with Delusion of Reference, run by Winthrop University Hospital 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 13 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 Dec 2016. 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. 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 the effects of 10000 IU/day vitamin D plus 2,000 mg/day calcium versus 600 IU/day vitamin D plus 2,000 mg/day calcium on incidence of hypercalciuria (spot urine calcium:creatinine ratio, 24-hour urine calcium). (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019381, which also lists 1 linked publication.
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 Dec 2016.