At the entire participants (patients and control group)

At the inception of the study, the
participants will be recruited. Then the diagnosis of the MS will be made using
Cerebral Spinal Fluid (CSF) analysis and Magnetic Resonance Imaging (MRI). The
baseline serum levels of the entire participants (patients and control group)
will be determined using the commercial kits. The values will be recorded and
kept for reference. Case group is important to eliminate confounding factors
that might lower vitamin D levels. The age, sex and the season (spring, summer,
autumn, winter) and symptom progression will also be recorded. Values will be
categorized as normal, insufficient and deficient. The final two values will be
considered as low vitamin D levels. It will be repeated at six months and one
year. This recording will continue for three years to recruit as many patients
as possible. After that serum analysis of the values will be made using the
Statistical Package of Social Science.

Literature Review

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There are various literature that
show the correlation between vitamin D and Multiple Sclerosis. The study by
Salzer et al. (2012) examined the levels of vitamin D with the risk of
developing MS. The study took place in Sweden and examined adequate population
sample of 164,000 participants. Both blood samples collected retrospectively
since 1975 and samples of pregnant mothers whose offspring later developed. The
study found that the levels of vitamin D above 75 nanomolar in the blood
samples were associated with minimal risk of developing MS.  The study also reported a significant
decrease in the prevalence of higher levels (more than 75 nanomolar) from the
year 1976 to 2005.  The report supports
the evidence that higher vitamin D decreases the risk of MS. It further concluded
that there are no gestational levels of vitamin D and development of MS in the
offspring (Salzer et al., 2012).

Pierrot-Deseilligny &
Souberbielle (2010) did a study to determine if low vitamin D levels are one of
the risk factors for developing MS.  They
emphasize that low vitamins are just but one of the risk factors for developing
MS. They are numerous other genetic and environmental factors that act in
synergy to cause the disease. Secondly, their review challenges the popular
belief about the physiology of Vitamin D. Vitamin D could have a significant
role as an immunomodulator and be involved in many autoimmune pathologies and
MS.  They argue that vitamin D is
required in higher amounts than commonly believed. That is why in medium or
high altitude areas that lack enough sunshine, the requirement is hardly met.

This fact adds to the previous studies that support altitude gradient.  Their review showed insufficient levels of
vitamin D in MS (Pierrot-Deseilligny & Souberbielle, 2010).  Based on their review of the questionable
significance and specificity of the results, it was found that low vitamin D
levels are likely to be one of the risk factors for MS. 

Mazdeh et al. (2013) also did a
study to compare serum levels of Vitamin D3 in patients with MS and their
healthy relatives.  75 patients newly
diagnosed with MS and 100 of their healthy relatives were recruited as a
control. The mean serum levels of vitamin D were found to be 11.3 and 17.9
nanograms per milliliter in the case and control groups respectively.  In comparison to the healthy control group,
the serum levels of vitamin D were found to be lower in people with MS. The
difference was especially profound in the female. The difference was also more significant
during the summer time. The study adds to the growing support that vitamin D
deficiency has a role (Mazdeh et al., 2013). However, the sample population is
not significant enough to yield reproducible results.

Ashtari et al. (2013) also did a
study to determine the correlation between the vitamin D levels and symptoms
(depression and fatigue) of MS.  The
cross-study was conducted in 2011 during summer.  48.5 percent of the 200 participants had low
levels of serum Vitamin D.  Their study
indicated that low vitamin D levels were associated with depressive symptoms
although the difference was minimal. There was no correlation between vitamin D
status and fatigue symptoms (Ashtari et al., 2013).

The studies yield varying results.

Although there is growing evidence of the role of vitamin D in MS and the
association of low vitamin D3 levels with MS, there is need to produce stronger
evidence.  Better studies with evident
methodology and ample sample population need to be carried out to yield more
reproducible and valid results. This study is a quantitative prospective study
that intends to produce a more apparent correlation between vitamin D and
MS.  The age and environmental effects on
vitamin D will be eliminated for a more valid result. 

Methodology

This study is a quantitative
prospective case-control study that will involve actual patients who have
Multiple sclerosis.  It will be carried
over two years to get more samples.   A
retrospective study relies on accurate data storage that might not be
available. Therefore, prospective study will be suitable. The quantitative
study is chosen as the actual number of patients, and the values of
cholecalciferol will be taken. The qualitative study will require the use of
focus-group discussion and interviewees to collect the data. Patients might not
know the serum values of their cholecalciferol. 
Therefore, the use of quantitative study where the author collects his
clinical data is rational and most appropriate. It is a case-control so that
the confounding factors can be eliminated. All the patients suffering from MS
in the health facility with the highest incidence and prevalence of MS will be
included. The author intends to include a sample size of 300 patients in the
next three years. In such a setting this number is practical and will provide
valid and reproducible findings. It is unlike the studies found in the
literature review that had 75 or 200 patients. 

Inclusion/Exclusion Criteria

Inclusion Criteria

ü 
The patients must be above 18 years of age

ü 
The diagnosis of multiple sclerosis is confirmed
by through the McDonald criteria of 2010 by Lumber puncture and CSF analysis
together with MRI with and without Gadolinium contrast. 

ü 
The relatives of the participants must consent
to act as the control group.

Exclusion Criteria

ü 
 Any
patient with diagnosis of MS who is on hormone supplementation, cyclosporine,
and lipid-lowering drugs

ü 
 Patients
and relatives who do not consent to the study

ü 
Patients below 18 years of age and above 65 years

ü 
Any patient who had supplementation with Vitamin
D six months before the commencement of the study

ü 
Patients who have MS and recurrent pregnancy

ü 
MS patients with endocrine disorders,
malabsorptive disease, and chronic renal disease

Data Collection

Baseline serum levels of
cholecalciferol will be determined for the patients and the control group. The
diagnosis of MS must be confirmed before recruiting the patients into the
study. The sampling of the participants will be done at the same time to avoid
time effect (seasonal) of vitamin D.  The
levels will be determined using commercial kits. The laboratory staff will be
blinded so that they are unaware of the control or the case samples. The levels
will be determined at baseline, after six months and at the end of the year.

Data Analysis

Data will be analyzed using
Statistical Package of Social Science version 24. The confidence interval level
will be set at 95%. The results will be expressed as standard deviation, and
the mean of the groups will be compared using student’s t-test. Graphical
charts will be generated to represent the information.

Ethical Consideration

The participants must be above the
legal age of the 18 years to participate in the study. Older patients (over 65
years) are also excluded as the length of the study might disturb them. There
will be no other form of coercion whatsoever to influence the participation of
the group. The study will not do any harm to the participants. No form of toxic
medications will be taken to the patients. Samples will be determined through
electrochemiluminescence that will not in any way affect the participants.

Above all, all the participants must agree and sign the consent form. The study
must be approved by the ethical review committee of the hospital/university.

Further, the participants are allowed to exit the study at whatever point they
wish.

Applicability to Nursing

The research will find if lack of
vitamin D has a causal role in Multiple Sclerosis. The evidence from the study
will yield answers vital to the nursing care. If evidence is found, the nurses
will treat patients and their caretakers appropriately.  Nursing measures such as vitamin D
supplementation and advice on total body exposure to sunlight will be handy in
the prevention of the disease.