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Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice (VITAD)

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ClinicalTrials.gov Identifier: NCT02518763
Recruitment Status : Unknown
Verified August 2015 by University Hospital, Caen.
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Vitamin D3, 100 000 IU weekly, 4 times Biological: 25 OH vitamin D serum concentration measurements Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2011
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3, 100 000 IU weekly, 4 times Drug: Vitamin D3, 100 000 IU weekly, 4 times
Biological: 25 OH vitamin D serum concentration measurements



Primary Outcome Measures :
  1. Serum 25 OH vitamin D concentration [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women ≥ 50 years
  • Osteoporosis with BMD T-score ≤ -2.7DS -2.5DS to at least one of the two main sites analyzed, with or without fracture
  • having signed an informed consent

Exclusion Criteria:

  • Taking a "loading dose" of vitamin D in the last six months (a daily intake in combination with calcium will not be a cause of exclusion but should be discontinued during the study).
  • Taking an osteoporosis treatment combined with vitamin D in the same tablet (or Adrovance Fosavance * *)
  • Treatment with thiazide diuretic
  • Known malabsorption (celiac disease)
  • Scalable Endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism.
  • Persistent or nephrolithiasis occurred in the previous 5 years
  • known sarcoidosis
  • Persons under guardianship or trusteeship
  • Hypercalcemia and hypercalciuria
  • 25OH vitamin D levels> 50ng / ml

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): NCT02518763


Locations
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France
University Hospital
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02518763    
Other Study ID Numbers: 08-090
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents