Address Factors That Assignment Help: How to Answer This Question
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What This Question Is About
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Structure your response with introduction, analysis, and conclusion.
Key Explanation
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Original Question
Address one of the factors that ISN’T included in the passage below (informed consent, special populations, blinding, incentives for volunteers, closing a study early) as it applies to your colleague’s study proposal. PASSAGE: Research Question and Purpose of Study Will maintaining an individual’s Vitamin D levels within therapeutic range reduce the number of illnesses they experience each year? Since Vitamin D plays a significant role in immune function, the expected outcome is that those in the Vitamin D group should experience fewer illnesses than the placebo group in a year. Independent Variable The independent variable in this experimental study would be serum Vitamin D levels. Vitamin D levels are considered low when below 75nmol/L, and the therapeutic range for Vitamin D is 100-<150nmol/L (Bleizgys, 2021). Dependent Variable The dependent variable in this experimental study would be the number of illnesses and individual experiences over the studied year. Baseline Measurement of Variables Measurement of the independent variable (Vitamin D level) would incorporate obtaining a baseline Vitamin D level through blood tests. Vitamin D is measured by testing 250H-D blood levels (Bleizgys, 2021). Measurement of the dependent variable (number of illnesses) would be performed by obtaining an individual's personal history of illnesses within the past year. This can be done by offering a questionnaire as well as collecting medical documentation from clinics/hospitals. Participant Selection Age Range: This study incorporates adults aged 18-65. Race/Ethnicity: All race and ethnicities are included in this study. Gender: Both genders are included in this study. Clinical History: Participants must have baseline Vitamin D levels below therapeutic range. Exclusion Criteria: Individuals with compromised immune systems or chronic illnesses that affect immunity, medical conditions that affect Vitamin D metabolism, and those already on Vitamin D supplementation. Intervention Vitamin D Group: One group will be provided Vitamin D supplementation to maintain Vitamin D levels within therapeutic range. Placebo Group: One group will be given a placebo pill with no active ingredients. Data Collection To ensure Vitamin D levels are maintained within therapeutic range, 250H-D levels as well as Calcium levels will be drawn on participants every 2-3 months (Bleizgys, 2021). Data will be collected on individual illnesses at the end of the study. This will be reported by participants via a health diary as well as any additional medical documentation from clinics/hospitals visited during the study. This experimental study will be an 18-month trial, allowing the first six months for participants to reach the therapeutic range of vitamin D. The monitoring of the number of illnesses will begin six months after the trial has begun, allowing one full year of illnesses to be reported. At the end of the study, the number of illnesses will be compared between the two groups. Single Blind Design A single-blind design is defined as a design where the participants are unaware of their group assignment, but the experimenter knows each participant's group status (Friis & Sellers, 2021). This study will follow a single blind design due to Vitamin D levels needing to be monitored and kept within range. Requirement of Informed Consent This study will require informed consent from every participant. An informed consent is a signed document that contains the purpose of the trial, the length of the trial, how the trial is to be performed, and the benefits and risks of the trial (Friis & Sellers, 2021). This document provides all needed information to the participants, and in return, their acknowledgement of the information received. Difference in Studies In this study, the independent variable (vitamin D level) is manipulated. In an observational study, we would observe the natural Vitamin D levels and see what takes place. In the case-control study discussed last week, we approached the effects of uncontrolled depression on HIV progression. The study was a retrospective study that collected previous data to determine the outcome. The independent variable was not manipulated nor were there any interventions placed. In this current experimental study, the trial is performed real-time with interventions to manipulate the independent variable. Data is then collected as the trial progresses and ultimately ends.
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