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Journal ClubThe effect of high-dose vitamin D supplementation on insulin resistance and arterial stiffness in patients with
type 2 diabetes
Prepared by: Amanda Bullock
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OverviewVitamin D reviewLiterature reviewJournal article
◦Purpose◦Methods◦Results◦Conclusion
Discussion
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Vitamin DHealth claims:
◦Promotes healthy bones by assisting with calcium absorption
◦Reduces risk of diabetes, heart disease, rheumatoid arthritis and multiple sclerosis
◦Regulates immune system
◦Prohibits cancer cell growth
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Vitamin DRecommended blood
level: 30-74ng/mL
Food sources: ◦Fatty fish: tuna, mackerel, salmon◦Cheese◦Egg yolks◦Fortified foods: milk, soy milk,
orange juice
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Vitamin DBest source: The SUN!
◦Dubbed the “sunshine vitamin”
◦Levels decrease during the winter months, especially if you are far from the equator
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(von Hurst, 2010)
Literature ReviewVitamin D supplementation reduces insulin resistance in South Asian women living in New Zealand who are insulin resistant and vitamin D deficient - a randomised, placebo-controlled trial.
A randomized, controlled, double-blind study was performed on 100 non-diabetic insulin-resistant Asian females. Participants were given 4,000 IU of Vitamin D daily for 6 months..
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(von Hurst, 2010)
Literature ReviewVitamin D supplementation reduces insulin resistance in South Asian women living in New Zealand who are insulin resistant and vitamin D deficient - a randomised, placebo-controlled trial.
When serum Vitamin D levels reached >32ng/mL, subjects showed significantly improved insulin resistance and sensitivity.
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(Witham, 2013)
Literature ReviewCholecalciferol treatment to reduce blood pressure in older patients with isolated systolic hypertension: the VitDISH randomized controlled trial
A parallel-group, double-blind, placebo-controlled randomized trial was conducted with 159 subjects >70 years old who had low levels of Vitamin D and isolated systolic hypertension. 1,000 IU of Vitamin D or a placebo was administered each day.
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(Witham, 2013)
Literature ReviewCholecalciferol treatment to reduce blood pressure in older patients with isolated systolic hypertension: the VitDISH randomized controlled trial
12 months later when the study concluded, no improvement was seen in blood pressure or other markers of vascular health.
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Authors’ Review of Current Data
“Vitamin D deficiency is more prevalent and severe in patients with type 2 diabetes compared with the normal population. Epidemiological studies revealed that vitamin D deficiency accompanied by type 2 diabetes is associated with an increased risk of all-cause and cardiovascular mortality.”
(Ohk-Hyun, 2014)
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PurposeMany claims have been made in
support of Vitamin D supplementation, especially in regards to diabetes and heart disease
This study aims to determine any impact on insulin resistance AND arterial stiffness secondary to Vitamin D supplementation in subjects with type 2 DM
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HypothesisAuthors hypothesize that insulin
resistance may link arterial stiffness and Vitamin D deficiency in type 2 DM…
(Ohk-Hyun, 2014)
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Subject Inclusion CriteriaDM2Vitamin D levels < 20ng/mLAmbulatory, aged 30-69 yearsHbA1c levels 6.5-8.4% Unchanged medications 3
months prior to studyNormal calcium levelsBMI > 23
(Ohk-Hyun, 2014)
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Subject Exclusion CriteriaUse of osteoporosis-related
medications within 3 months before study
Use of insulin 1 month before studySystolic BP >160mmHg or diastolic
BP >100mmHgAcute MI/stroke within 6 monthsAbnormal liver function testAlcoholism
(Ohk-Hyun, 2014)
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Methods: DesignProspective
Randomized
Double-blind
Placebo-controlled
(Ohk-Hyun, 2014)
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Methods: DesignFor 24 weeks, participants
received either:
◦1,000 IU Vitamin D with 100mg calcium twice daily (n = 40)
--or--◦Placebo containing 100mg of
calcium twice daily (n = 41)
(Ohk-Hyun, 2014)
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Methods: DesignParticipants were evaluated at:
◦Baseline
◦12 weeks +/- 2 weeks
◦24 weeks +/- 4 weeks
(Ohk-Hyun, 2014)
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Methods: DesignAll participants received
education regarding Vitamin D rich foods
Participants were instructed to maintain the same lifestyle as before the study
(Ohk-Hyun, 2014)
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Methods: DesignPhysicians not allowed to change
antihypertensive, antiplatelet or antilipid drugs during the study.
Only antidiabetic drugs allowed to be altered
(Ohk-Hyun, 2014)
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Methods: Outcome MeasuresVitamin D
levelsFasting glucose Lipid profilesHbA1cInsulin
The homeostasis model of assessment-IR [HOMA-IR]
High-sensitivity C-reactive protein
(Ohk-Hyun, 2014)
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Methods: Outcome MeasuresBrachial-ankle
pulse wave velocity
Radial augmentation index
Central systolic blood pressure
Safety of high-dose vitamin D supplementation◦Serum calcium◦Liver and kidney
function
(Ohk-Hyun, 2014)
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Methods: Data CollectionBlood pressure was tested after a
10-minute resting period
Blood tests were drawn after an overnight fast from 7pm-9am
Arterial stiffness was measured while the subject was in a supine position for 10 minutes
(Ohk-Hyun, 2014)
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(Ohk-Hyun, 2014)
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Statistical AnalysisAt the conclusion of the study, subjects
were evaluated if they: ◦Took the supplements/placebo >80% of the
time◦Didn’t change medications
A value of p < 0.05 was considered to be significant
Two-tailed t-tests were used to compare the Vitamin D and placebo group
A chi-square test was also used for categorical variables
(Ohk-Hyun, 2014)
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ResultsVitamin D levels (adequate = > 30
ng/mL):◦Placebo group: 10% (n = 3) ◦Vitamin D group: 68.8% (n = 22) ◦p < 0.001
No significant change in arterial stiffness or insulin resistance between the two groups◦(No significant change in any outcome
measure)(Ohk-Hyun, 2014)
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ResultsVitamin D supplementation at
2000 IU daily is safe in regards to liver/kidney function and serum calcium
(Ohk-Hyun, 2014)
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ConclusionsNo bias from the researchers was
evident
The conclusions are appropriate
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EALThe evidence in this article
receives an overall Fair (II) grade
Elements Grade
Quality Good (I)
Consistency Fair (II)
Quantity Fair (II)
Clinical Impact Limited (III)
Generalizability Fair (II)
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DiscussionPotential weaknesses of article:
◦All subjects on different medications
◦Low number or participants
◦Not a high amount of Vitamin D tested
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DiscussionDiscrepancies in conclusions of
different articles
◦More research needs to be done
◦Consensus of a correlation between Vit D and metabolic syndrome
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Discussion Questions
If there is a link between Vitamin D deficiency and metabolic
syndrome, should we fortify foods?
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Discussion Questions
Have any of you been asked about Vitamin D by patients? If so, what
have they asked?
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Discussion Questions
If a link was proven between DM2 or cardiovascular disease and Vitamin D deficiency, do you
think hospitals might incorporate supplements into clinical
practice?
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References
1. Ohk-Hyun R, Wankyo C, Sungwha L, Kyung-Soon H, Moon-Gi C, Hyung J Y. The effect of high-dose vitamin D supplementation on insulin resistance and arterial stiffness in patients with type 2 diabetes. Korean J Intern Med. 2014; 29(5): 620– 629.
2. von Hurst PR, Stonehouse W, Coad J. Vitamin D supplementation reduces insulin resistance in South Asian women living in New Zealand who are insulin resistant and vitamin D deficient: a randomised, placebo-controlled trial. Br J Nutr. 2010; 103: 549–555.
3. Witham MD, Price RJ, Struthers AD, et al. Cholecalciferol treatment to reduce blood pressure in older patients with isolated systolic hypertension: the VitDISH randomized controlled trial. JAMA Intern Med. 2013; 173: 1672–1679.