Description of practices regarding supplementation after HYPOvitaminosis-D investigation in middle-age community dwelling general population (HYPO-D Study)

Study identification

• EU PAS number:
  EUPAS3260
• Study ID:
  27493
• Official title and acronym:
  Description of practices regarding supplementation after HYPOvitaminosis-D investigation in middle-age community dwelling general population (HYPO-D Study)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Rational:Severe chronic vitamin D depletion in adults causes osteomalacia. Moderate to severe 25-hydroxyvitamin D (25(OH)D) deficiency is frequent, probably underdiagnosed, and possibly associated with the increase of other health outcomes. However, except in specific populations, the effect of vitamin D supplementation in deficient patients is still debated. Our purpose was to compare health care use after vitamin D supplementation versus before in patients likely to have 25(OH)D deficiency.Design - A before-after cohort study in a young to middle-aged population of patients with a prescription of 25(OH)D dosage from their physician was conductedSetting - The Insurance Healthcare System of the Rhône-Alpes area (France) database was used to follow ambulatory patients reimbursed for a 25(OH)D assay between December 1st 2008 and January 31th 2009.Interventions - Data on healthcare use were extracted over 5 months before and 5 months after the assay, including physician visits and medical interventions, number and type of drug prescriptions, mean number of drug classes per distinct prescriptions, medical imaging use, biology exams use, presence incident sick leaves, and incident hospitalizations.Outcomes : An individual was considered “25(OH)D deficient” if they had a record of a vitamin D assay for a dosage of 25(OH)D followed by vitamin D supplementation (i.e. at least one occurrence of vitamin D2 or Vitamin D3 delivery in the 3 months after the assay). Patients who were not prescribed vitamin D after their assay were considered as “not 25(OH)D deficient” and became part of the control group. The index date was the date of supplementation for the 25(OH)D deficient group and the date of 25(OH)D assay for the reference group. We compared the evolution of extracted data between the before and the after period.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hospices Civils de Lyon

Study timelines

Date when funding contract was signed

Planned:03/05/2010

Actual:03/05/2010

Study start date

Planned:07/06/2010

Actual:07/06/2010

Data analysis start date

Planned:07/11/2011

Actual:07/11/2011

Date of final study report

Planned:02/01/2012

Actual:27/02/2014

Sources of funding

Other

More details on funding

Hospices Civils de Lyon

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable