Study the Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Winthrop University Hospital
Sponsor:
Information provided by (Responsible Party):
John F. Aloia, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT02019381
First received: September 12, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Delusion of Reference
Dietary Supplement: Endocrine Society Upper Limit Dosage Vitamin D
Dietary Supplement: Institute of Medicine (IOM) Dosage Vitamin D
Dietary Supplement: Calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism in Postmenopausal White Women.

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    To test safety/efficacy of The Endocrine Society recommendations on Bone turnover.


Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Endocrine Society Upper Limit Dosage
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.
Dietary Supplement: Endocrine Society Upper Limit Dosage Vitamin D
Endocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium
Dietary Supplement: Calcium
Institute of Medicine (IOM) Dosage
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.
Dietary Supplement: Institute of Medicine (IOM) Dosage Vitamin D
IOM arm will get 600 IU Vitamin D and 1,200 mg Calcium
Dietary Supplement: Calcium

Detailed Description:

The specific aims of this study proposal are to determine the following:

  1. 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.
  2. 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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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).
  2. Willingness to discontinue self-administration of vitamin D and calcium supplements. Participants must be at least three months off supplements before starting the study.
  3. Willingness to take study medications and participate in study for one year.
  4. Written informed Consent Signed.
  5. Patients with hypertension and diabetes stable for last three months.

Exclusion Criteria:

  1. History of hypercalciuria (24-hour urinary calcium excretion >250 mg), hypercalcemia (serum calcium >10.6), nephrolithiasis and active sarcoidosis will be excluded.
  2. Serum 25-hydroxyvitamin D level >80 nmol/L or history of primary hyperparathyroidism.
  3. Dietary calcium intake of >2000mg/day will be excluded
  4. 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)
  5. Treatment with Hormone replacement therapy, Selective Estrogen Receptor Modulators, Calcitonin, Parathyroid hormone , androgens, bisphosphonates, phosphate or anabolic steroids 6 months prior to the study.
  6. 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.
  7. 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.
  8. Unexplained weight loss of >15% during the previous year or history of anorexia nervosa
  9. > 1 pack per day tobacco use or > 2 alcoholic beverages per day
  10. Unwillingness to forego self-administration of vitamin D and calcium-containing supplements.
  11. Participation in another investigational trial in the past 30 days prior to the screening evaluation
  12. Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator.
  13. Patients with unstable hypertension or diabetes.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019381

Contacts
Contact: Jane Moore, RN 516-663-4776 jmoore@winthrop.org
Contact: Migdalia Reid, RN 516-663-8223 mreid@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Alexander Schoen    516-663-4931    ASchoen@winthrop.org   
Contact: Jane Greensher, R.N    516-663-4776    jmoore@winthrop.org   
Sub-Investigator: Gianina L Usera, MD         
Sub-Investigator: Mikhail Mageda, MD         
Sub-Investigator: Jane Greensher, R.N         
Sub-Investigator: Migdalia Reid, R.N         
Principal Investigator: John Aloia, MD         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: John Aloia, MD Winthrop UH
Study Director: Mageda Mikhail, MD Winthrop UH
  More Information

Additional Information:
No publications provided

Responsible Party: John F. Aloia, MD, Chief Academic Officer, MD, Endocrinology., Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT02019381     History of Changes
Other Study ID Numbers: 13005
Study First Received: September 12, 2013
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Calcium, Dietary
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014