Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vitamin D Supplementation, Upper Respiratory Tract Infections, Immune and Physical Functions in Adolescent Swimmers
Brief Summary: Background: The medical and economic burden of upper respiratory tract infections (URTIs) is extremely high, while prevention and treatment options are limited. Therefore, there is a constant need for new methods in order to significantly decrease such morbidity. Extensive evidence shows that vitamin D is associated with respiratory health, including in the prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and can serve as a model for research in this field.

The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D levels will reduce the frequency, length, and severity of URTIs and their accompanying functional impairment, while improving cellular immune function and physical function.

Methods: After screening 100 competitive adolescent swimmers to obtain \~60 with low serum levels of vitamin D, this study group will be randomized to receive either vitamin D supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months. Participants will fill a daily questionnaire regarding frequency, length and severity of URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin D status (25(OH)D) and immune function among study participants at the beginning of the study and after supplementation. Physical function on land and in water will also be assessed.

Expected results: Increase in serum 25(OH)D levels following supplementation will significantly decrease the frequency, length and severity of URTI's and their functional impairment, while enhancing the cellular immune system function and physical capacity.


Options:
A: Inclusion Criteria:

* Aged 30-69 years at study entry.
* Must answer "Yes" to either "Have you had at least 2 colds in the last 12 months?" and/or "On average do you get at least 1 cold per year?"
* Prospective participants must meet the American Heart Association guidelines for suitability for an exercise program. Prospective participants will be advised (but not required) to seek their physicians' advice before enrollment.
* Self-reported ability and willingness to follow through with either exercise or meditation training, or neither, according to randomized allocation, and to participate in blood draws, nasal wash, self-report questionnaires, and weekly monitoring for 9 months.
* A score of 14 or lower on the PHQ-9 depression screen, self-reported both at entrance to run-in trial and again just prior to enrollment in the main study.
* Fluency and literacy in English language sufficient for understanding the study protocol and completing questionnaires.
* Successful completion of tasks during run-in period, including 2 in-person appointments, 1 phone contact, 1 set of homework questionnaires, and baseline nasal wash and blood draw.

Exclusion Criteria:

* Current or recent use of meditative practice, or previous meditation training. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you ever been trained in meditation? Have you ever been involved in a mindfulness class or mindfulness practice?
* Potential participants must not engage in moderate exercise more than twice per week or vigorous exercise more than once per week, as assessed by the following questions adapted from the Behavioral Risk Factor Surveillance System (BRFSS) classification system: On average, how many times per week do you engage in moderate recreational activities such as walking, tennis doubles, ballroom dancing, weight training, or similar activities that last at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 times per week; E) \>4 times per week. How many times per week do you engage in vigorous sport and recreational activities such as jogging, swimming, cycling, singles tennis, aerobic dance or other similar activities lasting at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 or more times per week.
* Women who are pregnant at screening or plan to become pregnant during the course of the study (determined by self-report) will be excluded. Women who become pregnant any time during the course of the trial will not be dropped and will continue to be followed throughout the duration of the study.
* Physical, medical or mental condition(s) precluding adherence to study protocol. Conditions include: malignant disease (prospective participants' physicians to advise and Dr. Barrett, and/or designee Dr. Rakel or Dr. Muller, to make final decision); and function-impairing psychopathology (prospective participants' psychiatrist or psychologist to advise). Questionable cases will be reviewed by the study physicians.
* True contraindication for influenza vaccine (flu shots) or refusal to accept influenza vaccine. Subjects will be asked to verify they have a) no known egg allergy, b) no prior reaction to influenza vaccine, and c) never been told they have Guillain-Barre Syndrome.
* Current use or forecasted need for immunoactive drugs (eg. steroids, immunosuppressants, chemotherapy); nonsteroidal antiinflammatories will be allowed.
* Immune deficiency or auto-immune disease (eg. HIV/AIDS, lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease). Questionable cases will be reviewed by study physicians.
B: Inclusion Criteria:

1. age 70 to 89 years; (2) summary score \<10 on the short physical performance battery (SPPB) (45% are \<8);90 (3) sedentary lifestyle; (4) ability to complete the 400 m walk test without an assistive device; and (5) willingness to be randomized to either intervention group.

   Exclusion Criteria:

   Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial • Unable or unwilling to give informed consent or accept randomization in either study group • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
   * Current consumption of more than 14 alcoholic drinks per week
   * Plans to relocate to out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year
   * Self-reported inability to walk across a small room
   * The use of a walker to complete the 400 m walk and/or unable to complete the 400 m walk without sitting down or the help of another person
   * Another member of the household is a participant in the Life Study
   * Residence too far from the intervention site
   * Residence in a nursing home
   * Difficulty in communication with study personnel due to speech or hearing problems
   * Modified Mini-Mental State Exam (3MSE) score below the cutoff for education:

   African American, 9+ yrs 76, \<9 yrs 70; English Speaking Non-African American, 9+ yrs 80, \<9 yrs 76; Spanish Speaking, 9+ yrs 80, \<9 yrs 70
   * Participation in LIFE-Pilot study
   * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

   Exclusion Criteria for Underlying Diseases Likely to Limit Lifespan and/or Affect the Safety of the Interventions

   • Severe arthritis (either osteoarthritis or rheumatoid arthritis)

   • Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)

   • Lung disease requiring either regular use of corticosteroid pills or injections or the use of supplemental oxygen

   • Development of chest pain or severe shortness of breath on a 400 m self-paced walk test

   • Cardiovascular disease (including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history or cardiac arrest, use of a cardiac defibrillator or uncontrolled angina)

   • Parkinson's disease or other serious neurological disorder

   • Renal disease requiring dialysis

   • Other illness of such severity that life expectancy is considered to be less than 12 months

   • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site

   Temporary Exclusion Criteria

   • Uncontrolled hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg).

   • Uncontrolled diabetes with recent weight loss, diabetic coma or frequent insulin reactions.
   * Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months.
   * Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (\>3 mm) on ECG.
   * Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months.
   * Undergoing physical therapy or cardiopulmonary rehabilitation
   * Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
C: Inclusion Criteria:

* members of swimming team
* training at least 15 hours/week
* low vitamin D plasma levels (\<30 ng/ml)
* signed consent forms

Exclusion Criteria:

* chronic health conditions
* taking prescription medications
* taking diet supplementations
D: Inclusion Criteria:

* clinical diagnosis of LRTI according to the international guidelines (i.e., presence cough and at least one of the following symptoms: sputum, dyspnoea, wheezes or chest pain)
* ≥ 18 years old
* able to provide their own informed consent

Exclusion Criteria:

* cognitive impairments
* inability to understand and co-operate
* bedridden or complete dependence on a wheelchair
* score \>2 in the CURB criteria
* presence of severe comorbidities (e.g., past history of pulmonary lobectomy and current history of neoplasia, tuberculosis or other infectious disease)

Answer: C