This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John F. Aloia, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00762775
First received: September 29, 2008
Last updated: December 10, 2014
Last verified: December 2014
  Purpose
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 Intervention
Osteoporosis Dietary Supplement: Calcium and vitamin D supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Interaction Between Calcium and Vitamin D Intake

Resource links provided by NLM:


Further study details as provided by John F. Aloia, MD, Winthrop University Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 78
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
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.
  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: 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
  More Information

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
Study First Received: September 29, 2008
Last Updated: December 10, 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
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 19, 2017