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The Interaction Between Calcium and Vitamin D Intake (PTH Modified)

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ClinicalTrials.gov Identifier: NCT00762775
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
John F. Aloia, MD, Winthrop University Hospital

Brief Summary:
We will study the relative importance of high calcium intake and vitamin D supplementation for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical bone markers. We also intend to examine the interaction of vitamin D and calcium intake on calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin D supplementation will lead to lower serum levels of PTH and markers of bone resorption compared with the placebo. We also theorize that when taken together, optimal calcium supplementation and optimal vitamin D intake will result in lower serum levels of PTH and bone markers compared with calcium or vitamin D taken alone.

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: Calcium and vitamin D supplementation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Interaction Between Calcium and Vitamin D Intake
Study Start Date : November 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Calcium supplementation and placebo
Dietary Supplement: Calcium and vitamin D supplementation
Arm 1: 1,200 mg daily of calcium supplementation and placebo; Arm 2: 100 microgram daily of Vitamin D and placebo; Arm 3: 1,200 mg of calcium and 100 microgram of Vitamin D daily; Arm 4: placebos only.

Experimental: 2
Vitamin D supplementation and placebo
Dietary Supplement: Calcium and vitamin D supplementation
Arm 1: 1,200 mg daily of calcium supplementation and placebo; Arm 2: 100 microgram daily of Vitamin D and placebo; Arm 3: 1,200 mg of calcium and 100 microgram of Vitamin D daily; Arm 4: placebos only.

Experimental: 3
Calcium and Vitamin D supplementation
Dietary Supplement: Calcium and vitamin D supplementation
Arm 1: 1,200 mg daily of calcium supplementation and placebo; Arm 2: 100 microgram daily of Vitamin D and placebo; Arm 3: 1,200 mg of calcium and 100 microgram of Vitamin D daily; Arm 4: placebos only.

Placebo Comparator: 4
Placebos only
Dietary Supplement: Calcium and vitamin D supplementation
Arm 1: 1,200 mg daily of calcium supplementation and placebo; Arm 2: 100 microgram daily of Vitamin D and placebo; Arm 3: 1,200 mg of calcium and 100 microgram of Vitamin D daily; Arm 4: placebos only.




Primary Outcome Measures :
  1. The influence of calcium supplementation alone on serum PTH levels and bone markers in healthy adult women. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The interaction between calcium and vitamin D supplementation and their combined effect on serum PTH hormone levels and bone markers in healthy adult women. [ Time Frame: 6 months ]


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women aged 45 and above who have been menopausal at least 1 year (absence of menstrual period for a period of 12 months or more)

Exclusion Criteria:

  • Any chronic medical illness including uncontrolled diabetes mellitus, recent history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, obesity (BMI>35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
  • Subjects with osteoporosis of the hip (total hip T-score equal or less than -2.5) or taking medications for osteoporosis such as bisphosphonates will be excluded.
  • Pregnancy.
  • Use of medication that influences bone metabolism (i.e. anticonvulsant medications, chronic use of steroids and high dose diuretics).
  • Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator.
  • Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis will also be excluded.
  • Participation in another investigational trial in the past 30 days prior to the screening evaluation.
  • Unexplained weight loss of >15% during the previous year or history of anorexia nervosa.
  • Medications that interfere with vitamin D metabolism.
  • Patients with a habitual dietary calcium intake that exceeds 800 mg/day.
  • Smokers greater than 1 pack per day will be excluded.
  • Patients reporting alcohol intake greater than 2 drinks daily.
  • Serum 25-hydroxyvitamin D level > 75 nmol/L.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762775


Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: John F. Aloia, MD Winthrop University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John F. Aloia, MD, Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00762775     History of Changes
Other Study ID Numbers: 33497
08016
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by John F. Aloia, MD, Winthrop University Hospital:
Bone resorption
Calcium homeostasis
Bone markers
Calcium and Vitamin D supplementation
Parathyroid hormone levels
Interaction between calcium and vitamin D supplementation

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents