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head: VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

Vitamin D Supplementation in Type II Diabetes

Noah J. Chappell
University of Massachusetts Medical School
Graduate School of Nursing

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

Abstract
Several studies have demonstrated a relationship between vitamin D levels and glycemic
control, although the efficacy of vitamin D as adjunct therapy for type II diabetes has not
been established. To determine the role of this nutrient in type II diabetes management, a
literature review was completed comparing standard type II diabetes therapy and adjunct
vitamin D supplementation to the use of standard therapy alone to improve hemoglobin
A1c in type II diabetics age 18 and older within a 6-month time period. To this end, a
search of the Cochrane Library, CINAHL, and PubMed was performed, which yielded 7
keeper studies responding to this PICOT question. These studies included 1 systematic
review and meta-analysis and 6 randomized controlled trials, representing level I and II
evidence respectively. Of these trials, 1 found a statistically significant effect and 6 found
no statistically significant effect of vitamin D on hemoglobin A1c after 3-6 months of
supplementation. Thus, the evidence demonstrates that vitamin D supplementation does
not influence glycemic control in type II diabetics and opposes the use of vitamin D as
adjunct therapy in clinical practice.

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

Introduction
Vitamin D is an essential nutrient in the human body that is obtained through
dietary sources, such as egg yokes and fatty fish, and through exposure to the sun. The
association between vitamin D and bone health is well established, and deficient levels
have been shown to cause rickets in children and osteomalacia in adults, conditions that
are prevented by appropriate supplementation (Woo, 2012). Beyond its effects on the
skeletal system, the presence of vitamin D receptors in most body tissues has provoked
speculation about the role of this nutrient in extra-skeletal health (McCance, 2010).
Several recent studies have demonstrated an association between vitamin D levels
and glycemic control (Sung, 2012). In one study involving healthy, glucose-tolerant
subjects, elevated vitamin D levels were correlated with increased insulin sensitivity,
while decreased levels were linked to beta cell dysfunction (Chiu, 2004). Another study
that enrolled pre-diabetic individuals (preprandial glucose 100125 mg/dl) associated
higher levels of vitamin D with a decreased rate of progression to type II diabetes
(Deleskog, 2012). In a third study, which recruited non-diabetic insulin resistant women
to participate in a randomized, controlled trial, decreased resistance and increased
sensitivity to insulin resulted from vitamin D supplementation (von Hurst, 2010).
These and similar studies have established the relationship between vitamin D
status and glycemic control, encouraging researchers to consider the potential role of
vitamin D in the treatment of type II diabetes. The following will address the clinical
trials that have aimed to investigate this role and to determine appropriate
supplementation for optimal disease management.

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

Background and Significance
Type II diabetes is a disease characterized by progressive insulin resistance and
eventual beta cell dysfunction (Buttaro, 2013). Once called adult-onset diabetes, type II
diabetes is now diagnosed in 5,089 individuals younger than 20 in the US annually, and
the disease is present within all age groups (CDC, 2014). Of the 29.1 million individuals
affected by diabetes nationally, 90-95% have type II diabetes, and much of the $245
billion expended annually in diabetes care goes to treat this form of the disease (CDC,
2014). All forms of diabetes collectively represent the seventh leading cause of death in
the US, with 234,051 deaths annually (CDC, 2014).
In addition to the economic burden and cost in life, type II diabetes correlates
with higher rates of morbidity among those affected (CDC, 2014). In 2010, the rate of
hospitalization was 1.8 times higher for heart attack and 1.5 times higher for stroke in
diabetic as opposed to non-diabetic adults 20 or older (CDC, 2014). Furthermore, 4.4%
of diabetic adults 40 or older were found to have advanced diabetic retinopathy from
2005 to 2008, and 44% of new cases of kidney failure in 2011 were attributed to some
form of diabetes (CDC, 2014).
Type II diabetes affects 90-95% of diabetic patients (CDC, 2014), and morbidity
and mortality have been show to decrease with a focus on modifiable risk factors and
glycemic control (Gregg, 2014). According to current guidelines, pre-prandial glucose
should be maintained from 70-130mg/dl, peak post-prandial glucose should be less than
180mg/dl, and HbA1c should remain below 7% in most adults with type II diabetes
(Uphold, 2013). Patients are recommended to adopt lifestyle modifications, such as
medical nutritional therapy and exercise, in addition to pharmacological therapy to meet

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

treatment goals. For most patients, it is recommended that pharmacological therapy begin
with an oral hypoglycemic agent, such as Metformin. If this is insufficient to manage
hyperglycemia, an agent from the sulfonylurea, pioglitazone, or DPP-4 class may be
added. Most patients with longstanding type II diabetes will eventually need to begin
insulin therapy to maintain disease control (Uphold, 2013). Type II diabetes is a treatable
disease, but its prevalence has only increased within the US (CDC, 2014). For this
reason, the investigation of adjunct treatments for type II diabetes, such as vitamin D
supplementation, is essential to reduce the burden of this disease on society.
Clinical Scenario
Richard is a 59-year-old white male with a 9-year history of type II diabetes who
lives in the community with his wife. At 5 feet, 9 inches tall and 189 pounds, he has a
BMI of 27.9 and is overweight. Richard does not use alcohol or tobacco, and further
medical history includes hypertension and GERD. For the first 7 years after diagnosis,
Richard maintained glycemic control by taking 1000mg of Glucophage XR nightly, with
an average fasting blood sugar (FBS) of 126 and HbA1c of 6.0%. In the last 2 years
however, his diabetes control has worsened. In December of 2012, Richard was informed
his HbA1c was 7.1% at a diabetes follow up appointment. During the previous 3 months,
he had noticed an increase in fasting blood sugar (FBS), but Richard and his provider
attributed this to overeating during the holidays, and no medication change was made.
From January to June of 2013, Richards FBS remained elevated, ranging from 143 to
180, and his HgA1c was 7.8% at recheck. His provider changed the order for 1000mg
Glucophage XR nightly to 1000mg Glucophage at breakfast and dinner. Although
improved, Richards HgA1c remained above goal at 7.2% at his follow-up appointment

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

in December 2013, and 10mg of Glucotrol taken before breakfast was added to his
regimen. With a HgA1c of 7.9% at recheck in June of 2014, this order was raised to
10mg Glucotrol twice daily, and Richard was begun on 10 units of Lantus insulin
injected nightly before bed (Uphold, 2013).
Richard is compliant with his pharmacological treatment, but he dislikes injecting
insulin and would like to find a more natural way to control his blood sugar. He is
willing to try increasing physical activity and eating lower-glycemic index foods, but he
states he has little time to exercise and does not want to offend his wife by not eating
what she cooks. Richards provider is aware of studies that associate a higher level of
vitamin D with glycemic control. In addition to lifestyle modification, consultation with a
nutritionist, insulin, and oral hypoglycemic agents, would vitamin D supplementation be
an effective treatment to help Richard manage his diabetes?
PICOT
For adults age 18 or older with type 2 diabetes (patient population), how does
adjunct therapy with vitamin D (intervention) compare to the use of standard therapy
alone (i.e. hypoglycemic agents with or without insulin) (comparison) to improve
hemoglobin A1c (outcome) within a 6-month time period (time)?
Search Process
The search for evidence commenced by entering the search string (vitamin D OR
cholecalciferol) AND (diabetes OR diabetes type 2) AND (hemoglobin A1c OR HbA1c
OR glycemic control). The databases included were the Cochrane Library, CINAHL, and
PubMed. Initially, the filters English language, human subjects, and publication date
from 2004 to 2014 were applied, which yielded 47 results in The Cochrane Library, 23

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

results in CINAHL, and 140 results in PubMed, for a total of 210 results. Only articles
published within the last 10 years were considered, as this interval would include a
sufficient quantity of contemporary research to inform evidence-based practice. After
eliminating repeat MEDLINE articles appearing in CINAHL and PubMed, a total of 193
articles remained. The search was further limited to systematic reviews, meta-analysis,
and randomized controlled trials, which produced a yield of 46 results in The Cochrane
Library, 6 results in CINAHL, and 51 results in PubMed, totaling 103 articles. The titles
and abstracts of these articles were then reviewed for relevance to the PICOT, and 11
articles were accepted. The final screening process produced 1 combined systematic
review and meta-analysis, and 10 randomized controlled trials.
Synthesis of Articles Critiqued
As outlined above, this critical analysis has sought to compare standard therapy
combined with adjunct vitamin D against standard therapy alone to improve hemoglobin
A1c in adult type II diabetics within a 6-month period. To this end, 11 studies were
identified and 7 keeper studies reviewed in detail for evidence relevant to this PICOT
question. Of the keeper studies, 1 randomized controlled trial concluded that adjunct
vitamin D therapy was a useful intervention for lowering A1c, while 1 combined
systematic review and meta-analysis and 5 randomized controlled trials produced
evidence against the use of vitamin D to reduce A1c. The greatest amount and highest
level of evidence opposes the use of vitamin D to lower A1c, and therefore this
intervention cannot be recommended as adjunct therapy for type II diabetes at this time.
The 7 keeper studies were largely similar in terms of design, subject
demographics, outcomes followed, and trial duration. Of the 7 keeper studies identified, 6

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

were double-blinded, randomized controlled trials that compared patients given vitamin
D3 (cholecalciferol) to patients receiving placebo, and 1 was a combined systemic
review and meta-analysis that synthesized multiple randomized controlled trials. Each
study accepted male and female subjects at least 18 years of age, although variation in
age range existed between studies. Each of the 7 studies tracked hemoglobin A1c and
insulin resistance as measures of glycemic control, and individual studies followed
additional glycemic indicators, such as beta cell function, fasting serum glucose, or serum
insulin. All studies were completed over a 3 to 6 month period.
Differences existed between the studies in the form of vitamin D supplementation
used, the frequency of administration, and the potency of each dose. Of the 7 keeper
studies, 4 studies gave oral vitamin D supplementation either twice daily, daily, weekly,
or at the beginning of the trial period, 2 studies provided an IM vitamin D injection either
initially or one time every 3 months, and 1 administered vitamin D-fortified yogurt twice
daily to subjects. Doses ranged from 500IU twice daily, to 300,000IU once every three
months. The treatment for type II diabetes permitted by the authors of each study also
varied. In 3 studies, subjects taking oral hypoglycemic agents alone were accepted, while
another 3 enrolled patients on a regimen of oral agents with or without insulin, and 1
required that subjects be treated w/ both oral agents and nightly insulin.
Notable strengths and limitations existed in the body of literature focused upon
vitamin D therapy in type II diabetes. A significant strength of the literature was the
availability of studies with a high level of evidence. Every study identified was of a
combined systematic review and meta-analysis or a randomized controlled trial design,
making each level I or level II evidence respectively. The contemporary nature of the

VITAMIN D SUPPLEMENTATION IN TYPE II DIABETES

evidence was another strength. The abundance of research produced recently allowed for
exclusion of studies published greater than 5 years ago, and it assured that only the most
current evidence would be reviewed. A limitation of the literature was its poor
generalizability to the US population, as reviewed studies were conducted in Iran,
Scotland, Switzerland, Norway, and Korea, and none included subjects dwelling within
the US. It is unclear whether factors such as ethnicity, climate, and diet would influence
outcomes differently in a US population. Another limitation was weak comparability
between studies in terms of vitamin D supplementation. Patients were administered doses
from 500IU to 300,000IU by IM injection or oral ingestion at a frequency ranging from
twice daily to once every three months. This great variability in vitamin D
supplementation may weaken conclusions drawn from the available evidence.
Among the studies reviewed, Jehle et al. (2014) conducted a double-blinded,
randomized controlled trial with the strongest internal validity. This study examined the
effect of MI vitamin D injections administered at 3-month intervals on HbA1c over a 6month period, and it found no significant change in this variable post study. While
recruitment of the 55 subjects was only briefly described, the authors minimized bias and
confounding by using an unassociated nurse to supervise supplement and placebo
administration and an unassociated pharmacist to perform randomization to study arms.
The authors reported preliminary subject characteristics to assure comparability at
baseline. There was no loss to follow-up, and data collection and statistical analysis were
described in detail.
By comparison, the double-blinded, randomized controlled trial by Ryu et al.
(2014) was the strongest reviewed in terms of sample size (n=158). This study

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determined the effect of twice-daily oral vitamin D on HbA1c over a 6-month period,
finding no significant change in the variable post intervention. In addition to a large
sample size, the enrollment process was outlined, study arms were comparable at
baseline, and there was a small loss to follow-up (n=3). However, the study lacked an
adequate description of the randomization process or of supplement administration, thus
calling into question the studys impartiality and internal validity.
Although it represents the highest level of evidence of any study reviewed, the
systematic review and meta-analysis by George et al. (2012) is weakened by its
supporting studies. The authors examined multiple glycemic indicators by synthesizing
15 randomized controlled trials, of which 4 were used to determine the effect of vitamin
D supplementation on hemoglobin A1c. Of these, the trial by Jorde et al. (2009) was a
repeat study included in the keeper studies, and the remaining 3 were eliminated from the
literature search for failing to meet inclusion criteria (i.e. published >5 years ago,
inadequate description of DMII treatment, focus on pre-diabetics). Although this
systematic review and meta-analysis offers some benefit in responding to the PICOT
question, its limitations must be considered before it is allowed to inform practice.
Discussion
A review of the literature focused upon vitamin D supplementation in type II
diabetics did not detect any controversy regarding this treatment.
Although the systematic review and meta-analysis by George et al. (2012)
included in the keeper studies has been reviewed above, and no other systematic review
or meta-analysis has been found pertaining to the PICOT, it will be of value to compare
the keeper studies to literature examining vitamin D supplementation and glycemic

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11

indicators in non-diabetic insulin resistant patients. Of the 7 keeper studies reviewed in

this critical analysis, only that by Shab-Bidar et al. (2011) showed a statistically
significant decrease in hemoglobin A1c after vitamin D supplementation, whereas the
remaining studies found no statistically significant change. In accordance with these
findings, of the 3 studies examining vitamin D supplementation in insulin resistant
patients reviewed during the literature search, only the randomized controlled trial by von
Hurst et al. (2010) showed a statistically significant increase in insulin sensitivity in
insulin resistant women receiving vitamin D over a 6 month period. The systematic
review and meta-analysis by Seida et al. (2014) did not find any statistically significant
change in insulin resistance, beta cell function, or hemoglobin A1c in insulin resistant
patients receiving vitamin D after a review of 35 randomized controlled trials. Finally,
the randomized controlled trial by Barengolts et al. (2015) found no significant
improvement in hemoglobin A1c in pre-diabetic (A1c 5.7-6.4%) African American men
after vitamin D supplementation. As has been shown in established type II diabetics, the
literature indicates that vitamin D supplementation is largely ineffective in improving
glycemic indicators in patients with insulin resistance.
After a comprehensive review of the literature, it is clear that current evidence
opposes the use of vitamin D as an adjunct treatment to improve hemoglobin A1c in type
II diabetics. Of the 7 keeper studies synthesized, including 1 systematic review and metaanalysis and 6 randomized controlled trials, only 1 showed a statistically significant
decrease in hemoglobin A1c after vitamin D supplementation, with the other 6 showing
no statistically significant change in this outcome. The conclusion drawn above is further
supported by the strength of the literature, which includes a relative abundance of

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12

recently published studies of a high level of evidence (level I or II). These studies were
conducted in Asia, Europe, Polynesia, and the Middle East, and subjects spanned a
diversity of ethnic backgrounds. Given that similar results were obtained across studies
despite such diversity, it is likely that conclusions are generalizable to all type II diabetics
irrespective of ethnicity.
Application to Scenario
The patient scenario above is focused upon Richard, a 59-year-old male with type
II diabetes who has experienced worsening glycemic control over the last 2 years. After
Richards medication regimen was increased to include Glucophage, Glucotrol, and
eventually Lantus insulin injections, Richard began to enquire about a more natural
way to control his blood sugar. Considering the evidence presented above, vitamin D
supplementation would not be an appropriate choice of adjunct therapy to help Richard
achieve glycemic control. Instead, Richards clinician should advise him to increase
aerobic exercise to 150 minutes and refer him to a nutritionist to begin medical nutritional
therapy (Uphold, 2013). Such lifestyle interventions would offer an evidence based
method of improving disease control that the patient may consider more natural, while
decreasing the economic and psychological burden of reliance upon multiple
medications.
The relationship between vitamin D and bone health is widely accepted, and
preliminary studies raised hope that supplementation of this nutrient might improve
glycemic control in type II diabetics (Woo, 2012). After a comprehensive literature
review, however, vitamin D has been shown to exert no influence on hemoglobin A1c in
this population. For this reason, this author recommends that practicing clinicians

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continue vitamin D supplementation to support bone health, but not as an adjunct

treatment for type II diabetes.
Indications for Further Research
To strengthen the body of evidence regarding the roll of vitamin D in type II
diabetes treatment, future studies with a larger sample size are needed, as these would
increase generalizability of outcomes to the greater population of type II diabetics
(LoBiondo-Wood, 2010). In addition, it is important that future studies enroll subjects
residing within the US if outcomes are to inform treatment of American patients. Type II
diabetes is a multifactorial disease with environmental and genetic components, and it is
essential that studies be performed within this target populations local environment for
external validity to be optimized (LoBiondo-Wood, 2010).

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