The Interaction Between Calcium and Vitamin D Intake (PTH Modified)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calcium and vitamin D supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone resorption, Calcium homeostasis, Bone markers, Calcium and Vitamin D supplementation, Parathyroid hormone levels, Interaction between calcium and vitamin D supplementation
Eligibility 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.
Sites / Locations
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Calcium supplementation and placebo
Vitamin D supplementation and placebo
Calcium and Vitamin D supplementation
Placebos only
Outcomes
Primary Outcome Measures
The influence of calcium supplementation alone on serum PTH levels and bone markers in healthy adult women.
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.
Full Information
NCT ID
NCT00762775
First Posted
September 29, 2008
Last Updated
December 10, 2014
Sponsor
Winthrop University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00762775
Brief Title
The Interaction Between Calcium and Vitamin D Intake
Acronym
PTH Modified
Official Title
The Interaction Between Calcium and Vitamin D Intake
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Winthrop University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone resorption, Calcium homeostasis, Bone markers, Calcium and Vitamin D supplementation, Parathyroid hormone levels, Interaction between calcium and vitamin D supplementation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Calcium supplementation and placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Vitamin D supplementation and placebo
Arm Title
3
Arm Type
Experimental
Arm Description
Calcium and Vitamin D supplementation
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebos only
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium and vitamin D supplementation
Intervention Description
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 Measure Information:
Title
The influence of calcium supplementation alone on serum PTH levels and bone markers in healthy adult women.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F. Aloia, MD
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24064695
Citation
Aloia JF, Dhaliwal R, Shieh A, Mikhail M, Islam S, Yeh JK. Calcium and vitamin d supplementation in postmenopausal women. J Clin Endocrinol Metab. 2013 Nov;98(11):E1702-9. doi: 10.1210/jc.2013-2121. Epub 2013 Sep 24.
Results Reference
derived
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The Interaction Between Calcium and Vitamin D Intake
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