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Completed

NCT Number: NCT00762775

The Interaction Between Calcium and Vitamin D Intake

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.

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Key information

Age range

45 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Winthrop University Hospital

Mineola, New York, 11501, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Winthrop University Hospital

Other

Registry information

Acronym: PTH Modified

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2008
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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