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Vitamin D Supplementation in Older Women (VIDOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00472823
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : March 14, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.

Condition or disease Intervention/treatment
Osteoporosis Aging Dietary Supplement: Vitamin D3 Dietary Supplement: Calcium Citrate (Citracal)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of RDA for Vitamin D in Caucasian and African American Women
Study Start Date : April 2007
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: vitamin D3 400 IU daily
vitamin D3 400 IU daily
Dietary Supplement: Vitamin D3
Orally for one year
Dietary Supplement: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal
Experimental: vitamin D3 800 IU daily
vitamin D3 800 IU daily
Dietary Supplement: Vitamin D3
Orally for one year
Dietary Supplement: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal
Experimental: vitamin D3 1600 IU daily
vitamin D3 1600 IU daily
Dietary Supplement: Vitamin D3
Orally for one year
Dietary Supplement: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal
Experimental: vitamin D3 2400 IU daily
vitamin D3 2400 IU daily
Dietary Supplement: Vitamin D3
Orally for one year
Dietary Supplement: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal
Experimental: vitamin D3 3200 IU daily
vitamin D3 3200 IU daily
Dietary Supplement: Vitamin D3
Orally for one year
Dietary Supplement: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal
Experimental: vitamin D3 4000 IU daily
vitamin D3 4000 IU daily
Dietary Supplement: Vitamin D3
Orally for one year
Dietary Supplement: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal
Experimental: vitamin D3 4800 IU daily
vitamin D3 4800 IU daily
Dietary Supplement: Vitamin D3
Orally for one year
Dietary Supplement: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal
Placebo Comparator: placebo
matched to vitamin D tablet
Dietary Supplement: Vitamin D3
Orally for one year


Outcome Measures

Primary Outcome Measures :
  1. Changes in Serum 25-hydroxyvitamin D (25OHD) and parathyroid hormone (PTH) levels [ Time Frame: Baseline, 6months,12 months ]

Secondary Outcome Measures :
  1. Calcium absorption [ Time Frame: Baseline and 12 months ]
    100mg calcium+ calcium45

  2. Serum/urine calcium [ Time Frame: Baseline and every 3 months ]
  3. Bone markers [ Time Frame: Baseline, and 12 months ]
  4. Bone density [ Time Frame: Baseline and 12 months ]
    spine,hip,total body,lateral

  5. Muscle strength [ Time Frame: Baseline,6 months,12 months ]
    leg strength( Cybex),timed up and go,hand grip,chair stand,gait speed,quiet stance,postural stability( biodex),standing balance

  6. Falls [ Time Frame: Baseline and every 3 months ]
    questionnaire

  7. Pulmonary function studies [ Time Frame: baseline and final test ]
    FEV1

  8. Genotyping [ Time Frame: one time ]
  9. Molecular studies of peripheral leucocytes [ Time Frame: baseline and final test ]
  10. Adult Depression Score [ Time Frame: baseline and 12 months ]
    questionnaire

  11. Physical Activity Scale form ( PASE) [ Time Frame: baseline,6 months,12 months ]
    questionnaire

  12. sun exposure [ Time Frame: baseline and every 3 months ]
    sun exposure form and skin color evaluation by a reflective meter (SmartProbe)

  13. Basic metabolic panel [ Time Frame: baseline and every 3 months ]
  14. serum 1,25 dihydroxyvitamin D [ Time Frame: baseline and 12 months ]
  15. quality of life [ Time Frame: baseline and 12 months ]
    questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   57 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 7 years post-menopause
  • Serum 25OHD level 5 ng/ml to 20 ng/ml
  • BMI less than or equal to 40 kg/m2
  • Willing to discontinue multivitamins that contain vitamin D during the study

Exclusion Criteria:

  • Cancer (except basal cell carcinoma) or terminal illness
  • Previous hip fracture
  • Hemiplegia (paralysis of one side of the body)
  • Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II
  • Kidney stones more than twice in a lifetime
  • Chronic renal failure
  • Evidence of chronic liver disease, including alcoholism
  • Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity
  • Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide or Fluoride) in the last 6 months
  • Previous treatment within the last 6 months with calcitonin or estrogen
  • Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months and not within the last 6 months
  • Anticonvulsant therapy
  • High dose thiazide therapy (more than 37.5 mg)
  • 24 hour urine calcium greater than 290 mg on 2 baseline tests
  • Serum calcium exceeding upper normal limit on 2 baseline tests
  • Bone Mineral Density T-score less than -3.0 for spine or hip
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472823


Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
National Institute on Aging (NIA)
Office of Dietary Supplements (ODS)
University of Nebraska
Investigators
Principal Investigator: J C Gallagher, MD Creighton University Medical Center
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00472823     History of Changes
Other Study ID Numbers: AG0081
1R01AG028168-01 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Creighton University:
cholecalciferol
vitamin D deficiency
bone density
dietary calcium
hypercalcemia
hypercalciuria

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents