Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The specific aims of this study proposal are to determine the following:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocrine Society UL Dosage Vitamin D | Dietary Supplement | Endocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Aloia, MD | Winthrop UH | Principal Investigator |
| Mageda Mikhail, MD | Winthrop UH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30180273 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Institute of Medicine Dosage Vitamin D | Dietary Supplement | IOM arm will get 600 IU Vitamin D and 1,200 mg Calcium |
|
| Calcium | Dietary Supplement | 1200mg of CaCO3 supplementation will be given to each participant in both groups |
|
| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
Not provided
Not provided