Vitamin D Supplementation in Older Women (VIDOS)

This study has been completed.
Sponsor:
Collaborators:
University of Nebraska
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00472823
First received: May 10, 2007
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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 Intervention
Osteoporosis
Aging
Drug: Vitamin D3
Drug: Calcium Citrate (Citracal)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of RDA for Vitamin D in Caucasian and African American Women

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Changes in Serum 25-hydroxyvitamin D (25OHD) and parathyroid hormone (PTH) levels [ Time Frame: Baseline, 6months,12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calcium absorption [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    100mg calcium+ calcium45

  • Serum/urine calcium [ Time Frame: Baseline and every 3 months ] [ Designated as safety issue: Yes ]
  • Bone markers [ Time Frame: Baseline, and 12 months ] [ Designated as safety issue: No ]
  • Bone density [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    spine,hip,total body,lateral

  • Muscle strength [ Time Frame: Baseline,6 months,12 months ] [ Designated as safety issue: No ]
    leg strength( Cybex),timed up and go,hand grip,chair stand,gait speed,quiet stance,postural stability( biodex),standing balance

  • Falls [ Time Frame: Baseline and every 3 months ] [ Designated as safety issue: No ]
    questionnaire

  • Pulmonary function studies [ Time Frame: baseline and final test ] [ Designated as safety issue: No ]
    FEV1

  • Genotyping [ Time Frame: one time ] [ Designated as safety issue: No ]
  • Molecular studies of peripheral leucocytes [ Time Frame: baseline and final test ] [ Designated as safety issue: No ]
  • Adult Depression Score [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • Physical Activity Scale form ( PASE) [ Time Frame: baseline,6 months,12 months ] [ Designated as safety issue: No ]
    questionnaire

  • sun exposure [ Time Frame: baseline and every 3 months ] [ Designated as safety issue: No ]
    sun exposure form and skin color evaluation by a reflective meter (SmartProbe)

  • Basic metabolic panel [ Time Frame: baseline and every 3 months ] [ Designated as safety issue: No ]
  • serum 1,25 dihydroxyvitamin D [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    questionnaire


Enrollment: 260
Study Start Date: April 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D3 400 IU daily
vitamin D3 400 IU daily
Drug: Vitamin D3
Orally for one year
Drug: 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
Drug: Vitamin D3
Orally for one year
Drug: 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
Drug: Vitamin D3
Orally for one year
Drug: 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
Drug: Vitamin D3
Orally for one year
Drug: 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
Drug: Vitamin D3
Orally for one year
Drug: 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
Drug: Vitamin D3
Orally for one year
Drug: 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
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
Other Name: Citracal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   57 Years and older
Genders 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
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: NCT00472823

Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
University of Nebraska
Investigators
Principal Investigator: J C Gallagher, MD Creighton University Medical Center
  More Information

Publications:
Additional 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
Study First Received: May 10, 2007
Last Updated: September 27, 2011
Health Authority: United States: Federal Government

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
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014