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Effectiveness and safety of vitamin D in relation to bone health.

Abstract To review and synthesize the literature in the following areas: the association of specific circulating 25(OH)D concentrations with bone health outcomes in children, women of reproductive age, postmenopausal women and elderly men; the effect of dietary intakes (foods fortified with vitamin D and/or vitamin D supplementation) and sun exposure on serum 25(OH)D; the effect of vitamin D on bone mineral density (BMD) and fracture or fall risk; and the identification of potential harms of vitamin D above current reference intakes.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title evidence report/technology assessment
Publication Year Start




PMID- 18088161
OWN - NLM
STAT- MEDLINE
DA  - 20071219
DCOM- 20080123
LR  - 20160323
IS  - 1530-4396 (Print)
IS  - 1530-4396 (Linking)
IP  - 158
DP  - 2007 Aug
TI  - Effectiveness and safety of vitamin D in relation to bone health.
PG  - 1-235
AB  - OBJECTIVES: To review and synthesize the literature in the following areas: the
      association of specific circulating 25(OH)D concentrations with bone health
      outcomes in children, women of reproductive age, postmenopausal women and elderly
      men; the effect of dietary intakes (foods fortified with vitamin D and/or vitamin
      D supplementation) and sun exposure on serum 25(OH)D; the effect of vitamin D on 
      bone mineral density (BMD) and fracture or fall risk; and the identification of
      potential harms of vitamin D above current reference intakes. DATA SOURCES:
      MEDLINE(R) (1966-June Week 3 2006); Embase (2002-2006 Week 25); CINAHL (1982-June
      Week 4, 2006); AMED (1985 to June 2006); Biological Abstracts (1990-February
      2005); and the Cochrane Central Register of Controlled Trials (2nd Quarter 2006).
      REVIEW METHODS: Two independent reviewers completed a multi-level process of
      screening the literature to identify eligible studies (title and abstract,
      followed by full text review, and categorization of study design per key
      question). To minimize bias, study design was limited to randomized controlled
      trials (RCTs) wherever possible. Study criteria for question one were broadened
      to include observational studies due to a paucity of available RCTs, and question
      four was restricted to systematic reviews to limit scope. Data were abstracted in
      duplicate and study quality assessed. Differences in opinion were resolved
      through consensus or adjudication. If clinically relevant and statistically
      feasible, meta-analyses of RCTs on vitamin D supplementation and bone health
      outcomes were conducted, with exploration of heterogeneity. When meta-analysis
      was not feasible, a qualitative systematic review of eligible studies was
      conducted. RESULTS: 167 studies met our eligibility criteria (112 RCTs, 19
      prospective cohorts, 30 case-controls and six before-after studies). The largest 
      body of evidence on vitamin D status and bone health was in older adults with a
      lack of studies in premenopausal women and infants, children and adolescents. The
      quality of RCTs was highest in the vitamin D efficacy trials for prevention of
      falls and/or fractures in older adults. There was fair evidence of an association
      between low circulating 25(OH)D concentrations and established rickets. However, 
      the specific 25(OH)D concentrations associated with rickets is uncertain, given
      the lack of studies in populations with dietary calcium intakes similar to North 
      American diets and the different methods used to determine 25(OH)D
      concentrations. There was inconsistent evidence of an association of circulating 
      25(OH)D with bone mineral content in infants, and fair evidence that serum
      25(OH)D is inversely associated with serum PTH. In adolescents, there was fair
      evidence for an association between 25(OH)D levels and changes in BMD. There were
      very few studies in pregnant and lactating women, and insufficient evidence for
      an association between serum 25(OH)D and changes in BMD during lactation, and
      fair evidence of an inverse correlation with PTH. In older adults, there was fair
      evidence that serum 25(OH)D is inversely associated with falls, fair evidence for
      a positive association with BMD, and inconsistent evidence for an association
      with fractures. The imprecision of 25(OH)D assays may have contributed to the
      variable thresholds of 25(OH)D below which the risk of fractures, falls or bone
      loss was increased. There was good evidence that intakes from vitamin D-fortified
      foods (11 RCTs) consistently increased serum 25(OH)D in both young and older
      adults. Eight randomized trials of ultraviolet (UV)-B radiation (artificial and
      solar exposure) were small and heterogeneous with respect to determination of the
      exact UV-B dose and 25(OH)D assay but there was a positive effect on serum
      25(OH)D concentrations. It was not possible to determine how 25(OH)D levels
      varied by ethnicity, sunscreen use or latitude. Seventy-four trials examined the 
      effect of vitamin D(3) or D(2) on 25(OH)D concentrations. Most trials used
      vitamin D(3), and the majority enrolled older adults. In three trials, there was 
      a greater response of serum 25(OH)D concentrations to vitamin D(3) compared to
      vitamin D(2), which may have been due to more rapid clearance of vitamin D(2) in 
      addition to other mechanisms. Meta-analysis of 16 trials of vitamin D(3) was
      consistent with a dose-response effect on serum 25(OH)D when comparing daily
      doses of <400 IU to doses >/= 400 IU. An exploratory analysis of the
      heterogeneity demonstrated a significant positive association comparable to an
      increase of 1 - 2 nmol/L in serum 25(OH)D for every 100 additional units of
      vitamin D although heterogeneity remained after adjusting for dose. Vitamin D(3) 
      in combination with calcium results in small increases in BMD compared to placebo
      in older adults although quantitative synthesis was limited due to variable
      treatment durations and BMD sites. The evidence for fracture reduction with
      vitamin D supplementation was inconsistent across 15 trials. The combined results
      of trials using vitamin D(3) (700 - 800 IU daily) with calcium (500 - 1,200 mg)
      was consistent with a benefit on fractures although in a subgroup analysis by
      setting, benefit was primarily in elderly institutionalized women (fair evidence 
      from two trials). There was inconsistent evidence across 14 RCTs of a benefit on 
      fall risk. However, a subgroup analysis showed a benefit of vitamin D in
      postmenopausal women, and in trials that used vitamin D(3) plus calcium. In
      addition, there was a reduction in fall risk with vitamin D when six trials that 
      adequately ascertained falls were combined. Limitations of the fall and fracture 
      trials included poor compliance with vitamin D supplementation, incomplete
      assessment of vitamin D status and large losses to follow-up. We did not find any
      systematic reviews that addressed the question on the level of sunlight exposure 
      that is sufficient to maintain serum 25(OH)D concentrations but minimizes risk of
      melanoma and non-melanoma skin cancer. There is little evidence from existing
      trials that vitamin D above current reference intakes is harmful. In most trials,
      reports of hypercalcemia and hypercalciuria were not associated with clinically
      relevant events. The Women's Health Initiative study did report a small increase 
      in kidney stones in postmenopausal women aged 50 to 79 years whose daily vitamin 
      D(3) intake was 400 IU (the reference intake for 50 to 70 years, and below the
      reference intake for > 70 years) combined with 1000 mg calcium. The increase in
      renal stones corresponded to 5.7 events per 10,000 person-years of exposure. The 
      women in this trial had higher calcium intakes than is seen in most
      post-menopausal women. CONCLUSIONS: The results highlight the need for additional
      high quality studies in infants, children, premenopausal women, and diverse
      racial or ethnic groups. There was fair evidence from studies of an association
      between circulating 25(OH)D concentrations with some bone health outcomes
      (established rickets, PTH, falls, BMD). However, the evidence for an association 
      was inconsistent for other outcomes (e.g., BMC in infants and fractures in
      adults). It was difficult to define specific thresholds of circulating 25(OH)D
      for optimal bone health due to the imprecision of different 25(OH)D assays.
      Standard reference preparations are needed so that serum 25(OH)D can be
      accurately and reliably measured, and validated. In most trials, the effects of
      vitamin D and calcium could not be separated. Vitamin D(3) (>700 IU/day) with
      calcium supplementation compared to placebo has a small beneficial effect on BMD,
      and reduces the risk of fractures and falls although benefit may be confined to
      specific subgroups. Vitamin D intake above current dietary reference intakes was 
      not reported to be associated with an increased risk of adverse events. However, 
      most trials of higher doses of vitamin D were not adequately designed to assess
      long-term harms.
FAU - Cranney, Ann
AU  - Cranney A
FAU - Horsley, Tanya
AU  - Horsley T
FAU - O'Donnell, Siobhan
AU  - O'Donnell S
FAU - Weiler, Hope
AU  - Weiler H
FAU - Puil, Lorri
AU  - Puil L
FAU - Ooi, Daylily
AU  - Ooi D
FAU - Atkinson, Stephanie
AU  - Atkinson S
FAU - Ward, Leanne
AU  - Ward L
FAU - Moher, David
AU  - Moher D
FAU - Hanley, David
AU  - Hanley D
FAU - Fang, Manchung
AU  - Fang M
FAU - Yazdi, Fatemeh
AU  - Yazdi F
FAU - Garritty, Chantelle
AU  - Garritty C
FAU - Sampson, Margaret
AU  - Sampson M
FAU - Barrowman, Nick
AU  - Barrowman N
FAU - Tsertsvadze, Alex
AU  - Tsertsvadze A
FAU - Mamaladze, Vasil
AU  - Mamaladze V
LA  - ENG
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Evid Rep Technol Assess (Full Rep)
JT  - Evidence report/technology assessment
JID - 101082681
RN  - 0 (Bone Density Conservation Agents)
RN  - 1406-16-2 (Vitamin D)
SB  - IM
MH  - Adolescent
MH  - Aged
MH  - Bone Density/physiology
MH  - Bone Density Conservation Agents/*therapeutic use
MH  - Bone and Bones/*drug effects
MH  - Child
MH  - Child, Preschool
MH  - Dietary Supplements
MH  - Female
MH  - Fractures, Bone/prevention & control
MH  - Humans
MH  - Infant
MH  - Lactation/physiology
MH  - Male
MH  - Osteoporosis, Postmenopausal/prevention & control
MH  - Pregnancy
MH  - Rickets/prevention & control
MH  - Sunlight/adverse effects
MH  - Ultraviolet Rays
MH  - Vitamin D/administration & dosage/adverse effects/blood/*therapeutic use
MH  - Vitamin D Deficiency/prevention & control
RF  - 282
PMC - PMC4781354
OID - NLM: PMC4781354
EDAT- 2007/12/20 09:00
MHDA- 2008/01/24 09:00
CRDT- 2007/12/20 09:00
PST - ppublish
SO  - Evid Rep Technol Assess (Full Rep). 2007 Aug;(158):1-235.

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