Journal club vitamin D deficency


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Journal club vitamin D deficency

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Journal club vitamin D deficency

  1. 1. Yassin M. ALSaleh
  2. 2. ‫تعالى‬ ‫قال‬: (‫تسرفوا‬ ‫وال‬ ‫واشربوا‬ ‫وكلوا‬‫انه‬ ‫املسرفين‬ ‫يحب‬ ‫ال‬)
  3. 3. Introduction  Adequate dietary intake of calcium (Ca2+) and vitamin D (VitD) in children is important to guarantee normal bone mineralization .  Ca2+ is also important in coagulation cascade, in neuromuscular excitability and contraction, in enzyme hormones and growth factors activity, in secretion of hormones and in cell growth and differentiation
  4. 4. Introduction  Dietary Recommended Intake (DRI) for Ca2+:  700 mg/day for children aged 1–3 years.  1000 mg/day for children aged 4–8 years.  1300 mg/day for children aged 9–10 year and adolescents.
  5. 5. Introduction  has a roles in both innate and adaptive immunity.  Also implicated in the prevention of a number of conditions including autoimmunity, atopic disorders, certain forms of cancer, chronic hepatitis C, obesity and cardiovascular diseases
  6. 6. Introduction  American Academy of Pediatrics (AAP) recommended daily intake is 400 IU of vit D for infants, children and adolescents .  Unfortunately, despite this recommandation, studies have reported a high rate of VitD insufficiency in the pediatric age  Rationale is a multi-factorial.  one of the reasons is the insufficient intake related to dietary habits.
  7. 7.  We investigated Ca2 + and VitD intake.  the efficacy and applicability of a nutritional intervention to aimed optimize Ca2+ and VitD intake in a population of healthy children. Objectives:
  8. 8. METHODS  The study protocol was approved by the Ethics Committee of the Medical School of the University of Naples"Federico II”.in Italy  a randomized controlled trial.  From December 2008 to February 2009,
  9. 9. Inclusion criteria  healthy subjects (male and female, age range 3–17 years) consecutively observed as outpatients at Department for routine clinical examination because vaccination program.
  10. 10. exclusion criteria  Malnutrition (defined as a weight/height ratio <5° centile).  presence of chronic systemic diseases (celiac disease, inflammatory bowel disease, food allergy, cystic fibrosis, malignancy, immunodeficiency, tuberculosis, geneticmetabolic disease, primitive bone disease, diabetes and endocrine disorder);  use of systemic steroids in the previous 3 months.  people who did not speak Italian properly and were not  able to understand the Italian language.  Households non-resident in the Campania region
  11. 11. METHODS  written consent was collected  data regarding auxological parameters and general clinical conditions were assessed by 3 pediatricians unaware of the study aims.
  12. 12. METHODS  3- day diary for dietary Ca2+ and VitD intake was recorded  The parents received written and oral instructions on, recording everything that the child ate or drank and noting the quantities.  Picture models of sizes of food were also provided.  All subjects with less than 70% of Ca2+ and VitD DRIs were invited to participate in the study
  13. 13. METHODS  Using a computer generated list, these subjects were randomly allocated into one of 2 groups of nutritional intervention:  Group 1, receiving dietary counseling plus administration of Ca2+ and VitD supplementation product containing 400 mg of Ca2+ and 400 IU of VitD  Group 2, receiving dietary counseling alone.
  14. 14. METHODS  VitD supplementation product was given directly to the parents/tutors of the enrolled child.  Each parent/tutor received eight bottles of the study product .  At the enrolment (T0) and after 4 months of nutritional intervention (T1), all subjects underwent to a blood sampling (6 ml) to determine serum Ca2+ and 25 hydroxy vitamin D (25(OH)D) levels
  15. 15. Statistical Analyses  estimated a sample size of 12 patients in each group in order to obtain a power of the study of 85%.  Statistical analysis was performed by researchers blinded to the type of treatment.  Results are reported as means and 95% confidence interval (CI).  The level of significance for all statistical tests was 2- sided, p< 0.05.
  16. 16. 2 groups 1st 24 taken Ca2+ and VitD intake <70% Agree , questionnaire filled eligible 184 150 82 24 12 10 12 10
  17. 17. RESULTS  At T0 the two groups showed similar Ca2 + and VitD intakes .  At T1 children in Group 1 showed a simultaneous improvement of VitD and Ca2+ intake.  At T1 children in Group 2 showed only a significant increase of Ca2+ intake, but not of VitD  Serum Ca2+ levels were similar in the two groups at T0 and at T1.
  18. 18. RESULTS  At baseline serum 25(OH)D levels were below the optimal value (≥30 ng/ml) in both groups.  After four months of nutritional intervention all subjects in Group 1 and only one child in Group 2 showed serum 25 (OH) D within normal value.
  19. 19. Critical appraisal
  20. 20. PICO Population: healthy children Intervention: counseling +supplements Control: counseling Out come: optimize Ca2+ and VitD intake. 23
  21. 21. Relevance 1. Does the study address a common problem in your practice? YES 2. Does the study address an important outcome to you or to your patient? (DOE vs. POEM). YES
  22. 22. Validity 1. Was the assignment of patients to treatment randomized? yes 2- Was the assignment concealed? yes 25
  23. 23. Validity 3- Were patients analyzed in the groups to which they were randomized (intention to treat analysis)? no  Was follow-up complete& long enough? complete but long enough ?? 26
  24. 24. Validity 3. Were the groups similar at the start of the trial? Baseline prognostic factors (demographics, co-morditity, disease severity, other known confounders) balanced? YES 4. Were patients, their clinicians, and study personnel 'blind' to treatment?  NO 27
  25. 25. Validity 5. Aside from the experimental intervention, were the groups treated equally? • Co-intervention? • Contamination? • Compliance? yes 28
  26. 26. Validity 6. Were all clinically important outcomes considered? NO, 29
  27. 27. Results clinical significance  Precision of the effect:  Confidence intervals?  yes 30
  28. 28. Applicability 1. Can you do the Intervention exactly as it is described in the paper YES 2. Is your Patient is similar to the population of the study? no 3. Are the likely treatment benefits worth the potential harms and costs? yes 31
  29. 29. Assuming that the study conclusion is true ,would it lead to a change in your practice?
  30. 30. CONCLUSION  According to our findings, a dietary counseling alone is unable to obtain an adequate VitD intake that is necessary for body health and to reach optimal 25(OH)D serum levels.
  31. 31. Appendages
  32. 32. level of evidence 35
  33. 33. GLOSSARY  Randomization: Ideally, a process that ensures every member of a population has an equal chance to be included in the study's sample.  Randomized Controlled Trial (RCT): A true experiment, in which the researcher randomly assigns some patients to at least one maneuver (treatment) and other patients to a placebo, or usual treatment. 36
  34. 34. GLOSSARY  Intention-to-treat Analysis: analyzed for according to the groups for which they were originally assigned . 37
  35. 35. Interquartile range  also called the midspread or middle fifty, is a measure of statistical dispersion, being equal to the difference between the third and first quartiles.  the distance between the 75th percentile and the 25th percentile. The IQR is essentially the range of the middle 50% of the data. Because it uses the middle 50%, the IQR is not affected by outliers or extreme values. 38
  36. 36. Interquartile range  Example  Compute the interquartile range for the sorted Cotinine data:  18, 33, 58, 67, 73, 93, 147  The 25th and 75th percentiles are the .25*(7+1) and .75*(7+1) = 2nd and 6th observations, respectively.  IQR = 93-33 = 60. 39