The Interaction Between Calcium and Vitamin D Intake

NCT ID: NCT00762775

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-06-30

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.

Conditions

Osteoporosis

Keywords

Bone resorption; Calcium homeostasis; Bone markers; Calcium and Vitamin D supplementation; Parathyroid hormone levels; Interaction between calcium and vitamin D supplementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Calcium supplementation and placebo

Group Type: EXPERIMENTAL

Calcium and vitamin D supplementation

Intervention Type: DIETARY_SUPPLEMENT

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.

2

Vitamin D supplementation and placebo

Group Type: EXPERIMENTAL

Calcium and vitamin D supplementation

Intervention Type: DIETARY_SUPPLEMENT

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.

3

Calcium and Vitamin D supplementation

Group Type: EXPERIMENTAL

Calcium and vitamin D supplementation

Intervention Type: DIETARY_SUPPLEMENT

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.

4

Placebos only

Group Type: PLACEBO_COMPARATOR

Calcium and vitamin D supplementation

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Winthrop University Hospital

OTHER

Sponsor Role: lead

Responsible Party

John F. Aloia, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John F. Aloia, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Locations

Winthrop University Hospital

Mineola, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24064695 (View on PubMed)

Other Identifiers

08016

Identifier Type: -

Identifier Source: secondary_id

33497

Identifier Type: -

Identifier Source: org_study_id