The Interaction Between Calcium and Vitamin D Intake

NCT00762775 | Completed

• 2 other identifiers: 3349708016
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The influence of calcium supplementation alone on serum PTH levels and bone markers in healthy adult women.

  6 months

Secondary Outcomes (1)

• 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

Study Arms (4)

1

EXPERIMENTAL

Calcium supplementation and placebo

Dietary Supplement: Calcium and vitamin D supplementation

2

EXPERIMENTAL

Vitamin D supplementation and placebo

Dietary Supplement: Calcium and vitamin D supplementation

3

EXPERIMENTAL

Calcium and Vitamin D supplementation

Dietary Supplement: Calcium and vitamin D supplementation

4

PLACEBO COMPARATOR

Placebos only

Dietary Supplement: Calcium and vitamin D supplementation

Interventions

Calcium and vitamin D supplementation 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.

1; 2; 3; 4

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (1)

• 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.

  PMID: 24064695 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Resorption

Interventions

Calcium

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• John F. Aloia, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: September 30, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)