This study investigated calcium and vitamin D intake in healthy children. 184 children with intake below recommendations were randomly assigned to receive dietary counseling plus calcium/vitamin D supplements (Group 1) or counseling alone (Group 2). After 4 months, Group 1 showed improved intake of both nutrients and optimal vitamin D levels, while Group 2 only improved calcium intake and had lower vitamin D levels. The study concludes that counseling alone is not sufficient to achieve adequate vitamin D intake.

1. Yassin M. ALSaleh

2. ‫تعالى‬ ‫قال‬:
(‫تسرفوا‬ ‫وال‬ ‫واشربوا‬ ‫وكلوا‬‫انه‬
‫املسرفين‬ ‫يحب‬ ‫ال‬)

4. 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

5. 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.

6. 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

7. 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.

8.  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:

9. 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,

10. 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.

11. 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

12. METHODS
 written consent was collected
 data regarding auxological parameters and general
clinical conditions were assessed by 3 pediatricians
unaware of the study aims.

13. 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

14. 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.

15. 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

16. 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.

17. 2 groups
1st 24 taken
Ca2+ and VitD
intake <70%
Agree ,
questionnaire filled
eligible 184
150
82
24
12
10
12
10

20. 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.

21. 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.

22. Critical
appraisal

23. PICO
Population: healthy
children
Intervention: counseling
+supplements
Control: counseling
Out come: optimize Ca2+
and VitD intake.
23

24. 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

25. Validity
1. Was the assignment of patients to
treatment randomized?
yes
2- Was the assignment concealed?
yes
25

26. 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

27. 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
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28. Validity
5. Aside from the experimental intervention,
were the groups treated equally?
• Co-intervention?
• Contamination?
• Compliance?
yes
28

29. Validity
6. Were all clinically important outcomes
considered?
NO,
29

30. Results clinical significance
 Precision of the effect:
 Confidence intervals?
 yes
30

31. 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

32. Assuming that the study
conclusion is true ,would
it lead to a change in
your practice?

33. 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.

34. Appendages

35. level of evidence
35

36. 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

37. GLOSSARY
 Intention-to-treat Analysis: analyzed for according to
the groups for which they were originally assigned .
37

38. 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

39. 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.
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