Study the Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism.
Condition: Delusion of Reference
MeSH terms: Delusions
Study type: Interventional

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.
    

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.
    

Intervention name(s): Endocrine Society UL Dosage Vitamin D; Institute of Medicine Dosage Vitamin D; Calcium
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Endocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium; IOM arm will get 600 IU Vitamin D and 1,200 mg Calcium; 1200mg of CaCO3 supplementation will be given to each participant in both groups
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research