The Interaction Between Calcium and Vitamin D Intake

Osteoporosis Clinical Trial

— PTH Modified  

Official title:

The Interaction Between Calcium and Vitamin D Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762775
• Other study ID #: 33497
• Secondary ID: 08016
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: December 10, 2014
• Start date: November 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2014
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.

Locations

Country	Name	City	State
United States	Winthrop University Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The influence of calcium supplementation alone on serum PTH levels and bone markers in healthy adult women.		6 months	No
Secondary	The interaction between calcium and vitamin D supplementation and their combined effect on serum PTH hormone levels and bone markers in healthy adult women.		6 months	No