Medical Research Methods Assignment
Added on 2020-03-16
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Medical Research Methods1
Title: Cohort study for evaluation of effect of vitamin D supplementation for pregnantladies with vitamin D deficiency on the incidence of Diabetes Mellitus type 1 in childrenfrom 5 to 10 years old in Jeddah city in Kingdom of Saudi AribiaBackground:Vitamin D has significant role in the bone health, it can cause rickets in children andosteolalacia in adults. It also plays important role in other disease like cardiovascular disease,cancer, autoimmune diseases and type 1 and type 2 diabetes mellitus. Vitamin D can bemeasured in the blood in the form of 25-hydroxy vitamin D (25OHD). Hypovitaminosis isobserved in both pregnant and non-pregnant women. Exposure to sunlight, environment,obesity and latitude are the common factors responsible for the occurrence ofhypovitaminosis in the children1. With the advancement of the gestation, there would bedecline in the 25OHD levels in the pregnant women. 25OHD passes through the placentalbarrier, hence foetus is mainly dependent on the vitamin D of mother. Vitamin D deficiencycan lead to different conditions in mother like pre-eclampsia, gestational diabetes, low birthweight, bacterial vaginosis, pre-term delivery and caesarean section2. Vitamin deficiency in the pregnancy can lead to occurrence of conditions like multiplesclerosis, cardiovascular disease, schizophrenia, certain cancers and other autoimmunediseases such as type 1 diabetes mellitus (T1DM) and lupus in children. It has been observedthat significant deficiency of vitamin D can occur between 24 – 28 weeks of gestation inwomen with gestational diabetes. 83 % of women with gestational diabetes exhibits 25OHDlevels <50 nmol/L3. Approximately 29 % women exhibits 25OHD levels <15 nmol/L4.Vitamin D can adversely affect glucose and insulin metabolism, as a result there would bedecrease in the energy availability for the foetus. There are few reports available for the roleof vitamin D in augmenting insulin sensitivity, however there is scarcity of valid evidence forit. One of the most probable reason for the TIDM in children may be suboptimal levels ofvitamin D. Pregnant need to be supplemented with vitamin D supplementation. Vitamin Dcan augment insulin sensitivity and it can reach threshold due to continuous supplementationof vitamin D5. There are challenges associated with the analysis of vitamin D and itscorrelation with health issues. This is mainly due to multiple actions of vitamin D, ubiquity ofvitamin D receptors in the body and prevalent nature of vitamin D deficiency. It is evidentthat multiple interactions can occur among vitamin deficiency, vitamin supplementation andT1DM. Hence, fixed relationship should be established among these factors. To understand2
these interactions, cohort study is planned in Jeddah city of Kingdom of Saudi Arabia. In thisstudy exposure-outcome relation will be studied in selected women from the Jeddah city.Aim: To collect data about vitamin D deficiency in pregnant women and foetus.To study interaction between vitamin D supplementation and TIDM in the children. Hypothesis: It can be hypothesized that vitamin D deficiency will lead to occurrence of T1DM in theirchildren. Another hypothesis can be stated that, vitamin D supplementation in women caneffectively manage TIDM in their children. Study design:In this study, cohort study design will be implemented. In cohort study, participants in thestudy generally share common characteristics. This study design will incorporate current andhistorical cohorts. These types of studies are considered as the true prospective studiesbecause data can collected prior to the knowledge of occurrence of disease6,7. In this studyalso data related to the vitamin D deficiency in women will be collected prior to theevaluation of the TIDM in their children. Participants in this study also share commoncharacteristic in the form of vitamin D deficiency in the pregnant women andsupplementation with the vitamin D. Children in the age group 5 – 10 years will be from thesame mothers with vitamin deficiency. This study will comprise of two parts : 1) collection ofdata for women with vitamin D deficiency from five top hospitals in Jeddah city. 2)Assessment of TIDM in children of 5 – 10 years of age. Intervention schedule:Work to be accomplishedYear 1QuartersYear 2QuartersYear 3Quarters123412341Ethics clearance XProject set-upXDevelop intervention XDevelop study instrumentsX3
Enrolment of study subjects and data collection XXImplementation of intervention XXXXEvaluation XXXXData entry & cleaningXXXXData analysis of trial XXXXPreparation of report and scientific papers XPopulation recruitment: This is a population based cohort study. In these types of studies longitudinal assessment ofexposure-outcome relationship can be measured. These types of studies have advantages likedetermination of distribution and prevalence rate of specific variable and unbiasedevaluations can be carried out8. 100 women as study subjects and 70 women as controls willbe enrolled in the study. Data of 100 pregnant women with vitamin D deficiency will becollected from the five top hospitals in Jeddah city. These women were kept on vitamin Dsupplementation. Data from the last 5 – 10 years records will be collected because we willevaluate occurrence of T1DM in children with age of 5 – 10 years. These all women will bebetween 20 – 35 years of age. These women will be from all the socioeconomic classes,urban and rural areas. 100 children of the same women selected in the first phase of the studywill be selected for the assessment of occurrence of T1DM. These children will be betweenage of 5 – 10 years. Out of these 100 children, population will again segregated into the boysand girls population. Ethical consideration: Ethical approval will be taken from the institute ethical committee for the conduct of thestudy. Approval will be taken from each hospital head for the collection of data related towomen with vitamin D deficiency. Informed consent will be taken from the women for datacollection and identity of the women will be kept confidential. Informed consent will betaken from the children and their parents for evaluation of T1DM. Provision will be made forthe children to withdraw from the study at any time point. Measurement outcomes:4
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