Vitamin D and Mortality: an Individual Participant Data Meta-analysis of Standardized 25-hydroxyvitamin D

NCT02438488 | Completed

• 1 other identifier: ODIN 1
• Study Type: observational
• Target: 26,916
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D deficiency is a risk factor for mortality but existing data are limited by missing standardization of laboratory methods for 25-hydroxyvitamin D (25\[OH\]D). In a European consortium of eight cohort studies we use protocols of the Vitamin D Standardization Program (VDSP) to obtain standardized 25(OH)D data. Individual participant data (IPD) meta-analyses using a one step procedure will be performed to study associations of original and standardized 25(OH)D with all-cause, cardiovascular, and cancer mortality.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Median follow-up time of the included studies ranges from 7.5 to 17.8 years

Secondary Outcomes (2)

• Cardiovascular mortality

  Follow-up time - Median follow-up time of the included studies ranges from 7.5 to 17.8 years

• Cancer mortality

  Follow-up time - Median follow-up time of the included studies ranges from 7.5 to 17.8 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The fourth Tromsø study, the Ludwigshafen Risk and Cardiovascular Health Study (LURIC), the Age, Gene/Environment Susceptibility-Reykjavik Study (AGES Reykjavik), the New Hoorn Study (NHS), the Aarhus Mammography Cohort Study, the German Health Interview and Examination Survey for Adults (DEGS) and the old and young cohort of the Longitudinal Study on Ageing in Amsterdam (LASA).

You may qualify if:

• Availability of quality bio-banked samples for uniform sampling and analysis of selected samples
• Validated prospective data on clinical outcomes
• Willingness to collaborate
• Expertise in the field.

You may not qualify if:

• Individuals with incomplete data on age, sex, body mass index (BMI), season of blood sampling, 25(OH)D levels, vital status at follow-up and follow-up-time.

Sponsors & Collaborators

• Medical University of Graz: lead
• European Union: collaborator

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (1)

• Gaksch M, Jorde R, Grimnes G, Joakimsen R, Schirmer H, Wilsgaard T, Mathiesen EB, Njolstad I, Lochen ML, Marz W, Kleber ME, Tomaschitz A, Grubler M, Eiriksdottir G, Gudmundsson EF, Harris TB, Cotch MF, Aspelund T, Gudnason V, Rutters F, Beulens JW, van 't Riet E, Nijpels G, Dekker JM, Grove-Laugesen D, Rejnmark L, Busch MA, Mensink GB, Scheidt-Nave C, Thamm M, Swart KM, Brouwer IA, Lips P, van Schoor NM, Sempos CT, Durazo-Arvizu RA, Skrabakova Z, Dowling KG, Cashman KD, Kiely M, Pilz S. Vitamin D and mortality: Individual participant data meta-analysis of standardized 25-hydroxyvitamin D in 26916 individuals from a European consortium. PLoS One. 2017 Feb 16;12(2):e0170791. doi: 10.1371/journal.pone.0170791. eCollection 2017.

  PMID: 28207791 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Stefan Pilz, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

AU (1)