Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00581828
First received: December 19, 2007
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass, functional status, measures of physical function and quality of life. I hypothesize that treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater retention of calcium within the bone reservoir and improved physical function, quality of life and muscle mass.


Condition Intervention Phase
Osteoporosis
Osteopenia
Vitamin D Deficiency
Hypoparathyroidism
Hypercalciuria
Hypercalcemia
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in Intestinal Calcium Absorption From Baseline to One Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    percent and true fractional calcium absorption


Enrollment: 19
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
Drug: Vitamin D
50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year)
Other Names:
  • Vitamin D
  • Vitamin D2
  • Ergocalciferol

Detailed Description:

Postmenopausal women with vitamin D insufficiency will participate in this one-year study. We will study the change in intestinal calcium absorption from baseline (vitamin D insufficiency) to follow up (vitamin D repletion and whether increased absorption results in subsequent increased retention of calcium within bone over the one-year interval as measured by bone densitometry. We will also study the effect of vitamin D repletion upon whole body muscle mass, quality of life and physical function.

A review of medical records and a screening visit will determine eligibility. Eligible and consenting subjects will present to the GCRC in the early morning and following baseline labs, will consume breakfast with a glass of orange juice enriched with a stable calcium isotope, and will receive 3 mg of another stable calcium isotope by intravenous injection. Over the next eight hours, blood will be taken a total of 9 more times and over the first 24 hours, all urine and stool will be collected for measurement of its calcium content.

Subsequently for the next five days, women will collect three urine specimens daily. Women will then receive vitamin D to treat vitamin D deficiency. Once vitamin D repletion is accomplished, all women will repeat their 24-hour visit and subsequent five-day urine collections. Women will maintain vitamin D repletion by taking a twice monthly tablet (50,000 IU) of vitamin D2. To confirm vitamin D repletion and safety over the full one year study, additional study visits will occur at 3, 6 and 12 months.

A bone density test at screening and twelve months will allow us to assess the effect of vitamin D repletion on whole body bone mass and skeletal mass. At each GCRC stay, 3, 6 and 12 months, women will complete questionnaires regarding quality of life and functional status and will perform the Timed Up and Go Test. Because we wish to maintain and confirm constant calcium intake throughout the one- year study, women will complete a calcium questionnaire at baseline, 3, 6 and 12 months.

With each subject's consent, we will collect one tube of blood and isolate its DNA. When sufficient knowledge is available regarding the pathophysiologic mechanisms whereby genetic polymorphisms impact calcium homeostasis, we will test for such DNA polymorphisms and relate genetic information with other data collected on calcium homeostasis.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women at least five years past onset of menopause, defined as date of last menses
  • serum 25(OH)D 16-24 ng/ml by reverse phase HPLC
  • calcium intake < or = 1,100 mg daily

Exclusion Criteria:

  • Intake of >1,100 mg of calcium per day through the combination of diet and supplements
  • Hypercalcemia (baseline serum calcium above the normal reference range)
  • Nephrolithiasis, documented in the medical record or by patient report
  • Inflammatory bowel disease, malabsorption, chronic diarrhea, or use of antibiotics within the past month
  • Creatinine >2.0 mg/dL
  • Hypercalciuria (baseline urine calcium: creatinine ratio >0.25)
  • Current use of medications known to interfere with vitamin D and/or calcium metabolism, including oral steroids or anticonvulsants
  • Ongoing or recent (past six months) use of bisphosphonates, estrogen compounds, calcitonin or teriparatide, as these compounds may independently affect retention of calcium within bone
  • Diagnosis of, or evidence for, osteomalacia, manifest by serum 25(OH)D < 16 ng/ml or the presence of at least two of the following blood tests: low calcium, low phosphorus, or elevated alkaline phosphatase (23).
  • Prior adult clinical fragility fracture or baseline T-score below -3.0 at the lumbar spine or femur
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581828

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Karen E Hansen, MD University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581828     History of Changes
Other Study ID Numbers: 2005-0159, 05-1235-02
Study First Received: December 19, 2007
Results First Received: July 6, 2012
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Calcium Absorption
Intestinal Absorption of Calcium
Fractional Calcium Absorption
Stable Calcium Isotopes
Hypovitaminosis D
Vitamin D
Bone Mineral Density
Physical Function

Additional relevant MeSH terms:
Hypoparathyroidism
Hypercalcemia
Hypercalciuria
Bone Diseases, Metabolic
Osteoporosis
Rickets
Vitamin D Deficiency
Avitaminosis
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Urological Manifestations
Signs and Symptoms
Parathyroid Diseases
Endocrine System Diseases
Bone Diseases
Musculoskeletal Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014