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

December 10, 2014 updated by: John F. Aloia, MD, Winthrop University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winthrop University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33497
  • 08016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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