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Clinical utility of vitamin d testing: an evidence-based analysis.

Abstract This report from the Medical Advisory Secretariat (MAS) was intended to evaluate the clinical utility of vitamin D testing in average risk Canadians and in those with kidney disease. As a separate analysis, this report also includes a systematic literature review of the prevalence of vitamin D deficiency in these two subgroups.This evaluation did not set out to determine the serum vitamin D thresholds that might apply to non-bone health outcomes. For bone health outcomes, no high or moderate quality evidence could be found to support a target serum level above 50 nmol/L. Similarly, no high or moderate quality evidence could be found to support vitamin D's effects in non-bone health outcomes, other than falls. VITAMIN D: Vitamin D is a lipid soluble vitamin that acts as a hormone. It stimulates intestinal calcium absorption and is important in maintaining adequate phosphate levels for bone mineralization, bone growth, and remodelling. It's also believed to be involved in the regulation of cell growth proliferation and apoptosis (programmed cell death), as well as modulation of the immune system and other functions. Alone or in combination with calcium, Vitamin D has also been shown to reduce the risk of fractures in elderly men (≥ 65 years), postmenopausal women, and the risk of falls in community-dwelling seniors. However, in a comprehensive systematic review, inconsistent results were found concerning the effects of vitamin D in conditions such as cancer, all-cause mortality, and cardiovascular disease. In fact, no high or moderate quality evidence could be found concerning the effects of vitamin D in such non-bone health outcomes. Given the uncertainties surrounding the effects of vitamin D in non-bone health related outcomes, it was decided that this evaluation should focus on falls and the effects of vitamin D in bone health and exclusively within average-risk individuals and patients with kidney disease. Synthesis of vitamin D occurs naturally in the skin through exposure to ultraviolet B (UVB) radiation from sunlight, but it can also be obtained from dietary sources including fortified foods, and supplements. Foods rich in vitamin D include fatty fish, egg yolks, fish liver oil, and some types of mushrooms. Since it is usually difficult to obtain sufficient vitamin D from non-fortified foods, either due to low content or infrequent use, most vitamin D is obtained from fortified foods, exposure to sunlight, and supplements.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title ontario health technology assessment series
Publication Year Start




PMID- 23074397
OWN - NLM
STAT- PubMed-not-MEDLINE
DA  - 20121017
DCOM- 20121018
LR  - 20151026
IS  - 1915-7398 (Electronic)
IS  - 1915-7398 (Linking)
VI  - 10
IP  - 2
DP  - 2010
TI  - Clinical utility of vitamin d testing: an evidence-based analysis.
PG  - 1-93
AB  - This report from the Medical Advisory Secretariat (MAS) was intended to evaluate 
      the clinical utility of vitamin D testing in average risk Canadians and in those 
      with kidney disease. As a separate analysis, this report also includes a
      systematic literature review of the prevalence of vitamin D deficiency in these
      two subgroups.This evaluation did not set out to determine the serum vitamin D
      thresholds that might apply to non-bone health outcomes. For bone health
      outcomes, no high or moderate quality evidence could be found to support a target
      serum level above 50 nmol/L. Similarly, no high or moderate quality evidence
      could be found to support vitamin D's effects in non-bone health outcomes, other 
      than falls. VITAMIN D: Vitamin D is a lipid soluble vitamin that acts as a
      hormone. It stimulates intestinal calcium absorption and is important in
      maintaining adequate phosphate levels for bone mineralization, bone growth, and
      remodelling. It's also believed to be involved in the regulation of cell growth
      proliferation and apoptosis (programmed cell death), as well as modulation of the
      immune system and other functions. Alone or in combination with calcium, Vitamin 
      D has also been shown to reduce the risk of fractures in elderly men (>/= 65
      years), postmenopausal women, and the risk of falls in community-dwelling
      seniors. However, in a comprehensive systematic review, inconsistent results were
      found concerning the effects of vitamin D in conditions such as cancer, all-cause
      mortality, and cardiovascular disease. In fact, no high or moderate quality
      evidence could be found concerning the effects of vitamin D in such non-bone
      health outcomes. Given the uncertainties surrounding the effects of vitamin D in 
      non-bone health related outcomes, it was decided that this evaluation should
      focus on falls and the effects of vitamin D in bone health and exclusively within
      average-risk individuals and patients with kidney disease. Synthesis of vitamin D
      occurs naturally in the skin through exposure to ultraviolet B (UVB) radiation
      from sunlight, but it can also be obtained from dietary sources including
      fortified foods, and supplements. Foods rich in vitamin D include fatty fish, egg
      yolks, fish liver oil, and some types of mushrooms. Since it is usually difficult
      to obtain sufficient vitamin D from non-fortified foods, either due to low
      content or infrequent use, most vitamin D is obtained from fortified foods,
      exposure to sunlight, and supplements. CLINICAL NEED: CONDITION AND TARGET
      POPULATION Vitamin D deficiency may lead to rickets in infants and osteomalacia
      in adults. Factors believed to be associated with vitamin D deficiency include:
      darker skin pigmentation,winter season,living at higher latitudes,skin
      coverage,kidney disease,malabsorption syndromes such as Crohn's disease, cystic
      fibrosis, andgenetic factors.Patients with chronic kidney disease (CKD) are at a 
      higher risk of vitamin D deficiency due to either renal losses or decreased
      synthesis of 1,25-dihydroxyvitamin D. Health Canada currently recommends that,
      until the daily recommended intakes (DRI) for vitamin D are updated, Canada's
      Food Guide (Eating Well with Canada's Food Guide) should be followed with respect
      to vitamin D intake. Issued in 2007, the Guide recommends that Canadians consume 
      two cups (500 ml) of fortified milk or fortified soy beverages daily in order to 
      obtain a daily intake of 200 IU. In addition, men and women over the age of 50
      should take 400 IU of vitamin D supplements daily. Additional recommendations
      were made for breastfed infants. A Canadian survey evaluated the median vitamin D
      intake derived from diet alone (excluding supplements) among 35,000 Canadians,
      10,900 of which were from Ontario. Among Ontarian males ages 9 and up, the median
      daily dietary vitamin D intake ranged between 196 IU and 272 IU per day. Among
      females, it varied from 152 IU to 196 IU per day. In boys and girls ages 1 to 3, 
      the median daily dietary vitamin D intake was 248 IU, while among those 4 to 8
      years it was 224 IU. VITAMIN D TESTING: Two laboratory tests for vitamin D are
      available, 25-hydroxy vitamin D, referred to as 25(OH)D, and
      1,25-dihydroxyvitamin D. Vitamin D status is assessed by measuring the serum
      25(OH)D levels, which can be assayed using radioimmunoassays, competitive
      protein-binding assays (CPBA), high pressure liquid chromatography (HPLC), and
      liquid chromatography-tandem mass spectrometry (LC-MS/MS). These may yield
      different results with inter-assay variation reaching up to 25% (at lower serum
      levels) and intra-assay variation reaching 10%. The optimal serum concentration
      of vitamin D has not been established and it may change across different stages
      of life. Similarly, there is currently no consensus on target serum vitamin D
      levels. There does, however, appear to be a consensus on the definition of
      vitamin D deficiency at 25(OH)D < 25 nmol/l, which is based on the risk of
      diseases such as rickets and osteomalacia. Higher target serum levels have also
      been proposed based on subclinical endpoints such as parathyroid hormone (PTH).
      Therefore, in this report, two conservative target serum levels have been
      adopted, 25 nmol/L (based on the risk of rickets and osteomalacia), and 40 to 50 
      nmol/L (based on vitamin D's interaction with PTH). ONTARIO CONTEXT: VOLUME
      #ENTITYSTARTX00026; COST: The volume of vitamin D tests done in Ontario has been 
      increasing over the past 5 years with a steep increase of 169,000 tests in 2007
      to more than 393,400 tests in 2008. The number of tests continues to rise with
      the projected number of tests for 2009 exceeding 731,000. According to the
      Ontario Schedule of Benefits, the billing cost of each test is $51.7 for 25(OH)D 
      (L606, 100 LMS units, $0.517/unit) and $77.6 for 1,25-dihydroxyvitamin D (L605,
      150 LMS units, $0.517/unit). Province wide, the total annual cost of vitamin D
      testing has increased from approximately $1.7M in 2004 to over $21.0M in 2008.
      The projected annual cost for 2009 is approximately $38.8M. EVIDENCE-BASED
      ANALYSIS: The objective of this report is to evaluate the clinical utility of
      vitamin D testing in the average risk population and in those with kidney
      disease. As a separate analysis, the report also sought to evaluate the
      prevalence of vitamin D deficiency in Canada. The specific research questions
      addressed were thus: What is the clinical utility of vitamin D testing in the
      average risk population and in subjects with kidney disease?What is the
      prevalence of vitamin D deficiency in the average risk population in Canada?What 
      is the prevalence of vitamin D deficiency in patients with kidney disease in
      Canada?Clinical utility was defined as the ability to improve bone health
      outcomes with the focus on the average risk population (excluding those with
      osteoporosis) and patients with kidney disease. LITERATURE SEARCH: A literature
      search was performed on July 17th, 2009 using OVID MEDLINE, MEDLINE In-Process
      and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied
      Health Literature (CINAHL), the Cochrane Library, and the International Agency
      for Health Technology Assessment (INAHTA) for studies published from January 1,
      1998 until July 17th, 2009. Abstracts were reviewed by a single reviewer and, for
      those studies meeting the eligibility criteria, full-text articles were obtained.
      Reference lists were also examined for any additional relevant studies not
      identified through the search. Articles with unknown eligibility were reviewed
      with a second clinical epidemiologist, then a group of epidemiologists until
      consensus was established. The quality of evidence was assessed as high,
      moderate, low or very low according to GRADE methodology. Observational studies
      that evaluated the prevalence of vitamin D deficiency in Canada in the population
      of interest were included based on the inclusion and exclusion criteria listed
      below. The baseline values were used in this report in the case of interventional
      studies that evaluated the effect of vitamin D intake on serum levels. Studies
      published in grey literature were included if no studies published in the
      peer-reviewed literature were identified for specific outcomes or subgroups.
      Considering that vitamin D status may be affected by factors such as latitude,
      sun exposure, food fortification, among others, the search focused on prevalence 
      studies published in Canada. In cases where no Canadian prevalence studies were
      identified, the decision was made to include studies from the United States,
      given the similar policies in vitamin D food fortification and recommended daily 
      intake. INCLUSION CRITERIA: Studies published in EnglishPublications that
      reported the prevalence of vitamin D deficiency in CanadaStudies that included
      subjects from the general population or with kidney diseaseStudies in children or
      adultsStudies published between January 1998 and July 17(th) 2009 EXCLUSION
      CRITERIA: Studies that included subjects defined according to a specific disease 
      other than kidney diseaseLetters, comments, and editorialsStudies that measured
      the serum vitamin D levels but did not report the percentage of subjects with
      serum levels below a given threshold OUTCOMES OF INTEREST: Prevalence of serum
      vitamin D less than 25 nmol/LPrevalence of serum vitamin D less than 40 to 50
      nmol/LSerum 25-hydroxyvitamin D was the metabolite used to assess vitamin D
      status. Results from adult and children studies were reported separately.
      Subgroup analyses according to factors that affect serum vitamin D levels (e.g., 
      seasonal effects, skin pigmentation, and vitamin D intake) were reported if
      enough information was provided in the studies QUALITY OF EVIDENCE: The quality
      of the prevalence studies was based on the method of subject recruitment and
      sampling, possibility of selection bias, and generalizability to the source
      population. The overall quality of the trials was examined according to the GRADE
      Working Group criteria. (ABSTRACT TRUNCATED)
CN  - Health Quality Ontario
LA  - eng
PT  - Journal Article
DEP - 20100201
PL  - Canada
TA  - Ont Health Technol Assess Ser
JT  - Ontario health technology assessment series
JID - 101521610
PMC - PMC3377517
OID - NLM: PMC3377517
EDAT- 2010/01/01 00:00
MHDA- 2010/01/01 00:01
CRDT- 2012/10/18 06:00
PHST- 2010/02/01 [epublish]
PST - ppublish
SO  - Ont Health Technol Assess Ser. 2010;10(2):1-93. Epub 2010 Feb 1.

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