At the inception of the study, theparticipants will be recruited. Then the diagnosis of the MS will be made usingCerebral Spinal Fluid (CSF) analysis and Magnetic Resonance Imaging (MRI). Thebaseline serum levels of the entire participants (patients and control group)will be determined using the commercial kits. The values will be recorded andkept for reference. Case group is important to eliminate confounding factorsthat might lower vitamin D levels. The age, sex and the season (spring, summer,autumn, winter) and symptom progression will also be recorded. Values will becategorized as normal, insufficient and deficient.
The final two values will beconsidered as low vitamin D levels. It will be repeated at six months and oneyear. This recording will continue for three years to recruit as many patientsas possible. After that serum analysis of the values will be made using theStatistical Package of Social Science. Literature ReviewThere are various literature thatshow the correlation between vitamin D and Multiple Sclerosis.
The study bySalzer et al. (2012) examined the levels of vitamin D with the risk ofdeveloping MS. The study took place in Sweden and examined adequate populationsample of 164,000 participants. Both blood samples collected retrospectivelysince 1975 and samples of pregnant mothers whose offspring later developed. Thestudy found that the levels of vitamin D above 75 nanomolar in the bloodsamples were associated with minimal risk of developing MS.
The study also reported a significantdecrease in the prevalence of higher levels (more than 75 nanomolar) from theyear 1976 to 2005. The report supportsthe evidence that higher vitamin D decreases the risk of MS. It further concludedthat there are no gestational levels of vitamin D and development of MS in theoffspring (Salzer et al., 2012). Pierrot-Deseilligny &Souberbielle (2010) did a study to determine if low vitamin D levels are one ofthe risk factors for developing MS. Theyemphasize that low vitamins are just but one of the risk factors for developingMS. They are numerous other genetic and environmental factors that act insynergy to cause the disease.
Secondly, their review challenges the popularbelief about the physiology of Vitamin D. Vitamin D could have a significantrole as an immunomodulator and be involved in many autoimmune pathologies andMS. They argue that vitamin D isrequired in higher amounts than commonly believed. That is why in medium orhigh 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 ofvitamin D in MS (Pierrot-Deseilligny & Souberbielle, 2010). Based on their review of the questionablesignificance and specificity of the results, it was found that low vitamin Dlevels are likely to be one of the risk factors for MS. Mazdeh et al.
(2013) also did astudy to compare serum levels of Vitamin D3 in patients with MS and theirhealthy relatives. 75 patients newlydiagnosed with MS and 100 of their healthy relatives were recruited as acontrol. The mean serum levels of vitamin D were found to be 11.3 and 17.9nanograms 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.
Thedifference was especially profound in the female. The difference was also more significantduring the summer time. The study adds to the growing support that vitamin Ddeficiency has a role (Mazdeh et al., 2013). However, the sample population isnot significant enough to yield reproducible results.Ashtari et al.
(2013) also did astudy to determine the correlation between the vitamin D levels and symptoms(depression and fatigue) of MS. Thecross-study was conducted in 2011 during summer. 48.
5 percent of the 200 participants had lowlevels of serum Vitamin D. Their studyindicated that low vitamin D levels were associated with depressive symptomsalthough the difference was minimal. There was no correlation between vitamin Dstatus 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 theassociation of low vitamin D3 levels with MS, there is need to produce strongerevidence. Better studies with evidentmethodology and ample sample population need to be carried out to yield morereproducible and valid results. This study is a quantitative prospective studythat intends to produce a more apparent correlation between vitamin D andMS.
The age and environmental effects onvitamin D will be eliminated for a more valid result. MethodologyThis study is a quantitativeprospective case-control study that will involve actual patients who haveMultiple sclerosis. It will be carriedover two years to get more samples. Aretrospective study relies on accurate data storage that might not beavailable.
Therefore, prospective study will be suitable. The quantitativestudy is chosen as the actual number of patients, and the values ofcholecalciferol will be taken. The qualitative study will require the use offocus-group discussion and interviewees to collect the data.
Patients might notknow the serum values of their cholecalciferol. Therefore, the use of quantitative study where the author collects hisclinical data is rational and most appropriate. It is a case-control so thatthe confounding factors can be eliminated.
All the patients suffering from MSin the health facility with the highest incidence and prevalence of MS will beincluded. The author intends to include a sample size of 300 patients in thenext three years. In such a setting this number is practical and will providevalid and reproducible findings.
It is unlike the studies found in theliterature review that had 75 or 200 patients. Inclusion/Exclusion CriteriaInclusion Criteriaü The patients must be above 18 years of ageü The diagnosis of multiple sclerosis is confirmedby through the McDonald criteria of 2010 by Lumber puncture and CSF analysistogether with MRI with and without Gadolinium contrast. ü The relatives of the participants must consentto act as the control group.Exclusion Criteriaü Anypatient with diagnosis of MS who is on hormone supplementation, cyclosporine,and lipid-lowering drugsü Patientsand relatives who do not consent to the studyü Patients below 18 years of age and above 65 yearsü Any patient who had supplementation with VitaminD six months before the commencement of the studyü Patients who have MS and recurrent pregnancyü MS patients with endocrine disorders,malabsorptive disease, and chronic renal diseaseData CollectionBaseline serum levels ofcholecalciferol will be determined for the patients and the control group. Thediagnosis of MS must be confirmed before recruiting the patients into thestudy. The sampling of the participants will be done at the same time to avoidtime effect (seasonal) of vitamin D.
Thelevels will be determined using commercial kits. The laboratory staff will beblinded so that they are unaware of the control or the case samples. The levelswill be determined at baseline, after six months and at the end of the year. Data AnalysisData will be analyzed usingStatistical Package of Social Science version 24. The confidence interval levelwill be set at 95%. The results will be expressed as standard deviation, andthe mean of the groups will be compared using student’s t-test.
Graphicalcharts will be generated to represent the information. Ethical ConsiderationThe participants must be above thelegal age of the 18 years to participate in the study. Older patients (over 65years) are also excluded as the length of the study might disturb them. Therewill be no other form of coercion whatsoever to influence the participation ofthe group. The study will not do any harm to the participants. No form of toxicmedications will be taken to the patients. Samples will be determined throughelectrochemiluminescence that will not in any way affect the participants.
Above all, all the participants must agree and sign the consent form. The studymust be approved by the ethical review committee of the hospital/university.Further, the participants are allowed to exit the study at whatever point theywish. Applicability to NursingThe research will find if lack ofvitamin D has a causal role in Multiple Sclerosis. The evidence from the studywill yield answers vital to the nursing care.
If evidence is found, the nurseswill treat patients and their caretakers appropriately. Nursing measures such as vitamin Dsupplementation and advice on total body exposure to sunlight will be handy inthe prevention of the disease.