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
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
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
American Academy of Pediatrics (AAP) recommended
daily intake is 400 IU of vit D for infants, children and
Unfortunately, despite this recommandation, studies
have reported a high rate of VitD insufficiency in the
Rationale is a multi-factorial.
one of the reasons is the insufficient intake related to
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.
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,
healthy subjects (male and female, age range 3–17
years) consecutively observed as outpatients at
Department for routine clinical examination because
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
written consent was collected
data regarding auxological parameters and general
clinical conditions were assessed by 3 pediatricians
unaware of the study aims.
3- day diary for dietary Ca2+ and VitD intake was
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
Using a computer generated list, these subjects were
randomly allocated into one of 2 groups of nutritional
Group 1, receiving dietary counseling plus
administration of Ca2+ and VitD supplementation
product containing 400 mg of Ca2+ and 400 IU of
Group 2, receiving dietary counseling alone.
VitD supplementation product was given directly to
the parents/tutors of the enrolled child.
Each parent/tutor received eight bottles of the study
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
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
The level of significance for all statistical tests was 2-
sided, p< 0.05.
1st 24 taken
Ca2+ and VitD
At T0 the two groups showed similar Ca2 + and VitD
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.
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.
Out come: optimize Ca2+
and VitD intake.
1. Does the study address a common problem
in your practice?
2. Does the study address an important
outcome to you or to your patient? (DOE vs.
1. Was the assignment of patients to
2- Was the assignment concealed?
3- Were patients analyzed in the groups to
which they were randomized (intention to
Was follow-up complete& long enough?
complete but long enough ??
3. Were the groups similar at the start of the
trial? Baseline prognostic factors
(demographics, co-morditity, disease
severity, other known confounders)
4. Were patients, their clinicians, and study
personnel 'blind' to treatment?
5. Aside from the experimental intervention,
were the groups treated equally?
6. Were all clinically important outcomes
Results clinical significance
Precision of the effect:
1. Can you do the Intervention exactly as it is
described in the paper
2. Is your Patient is similar to the population of the
3. Are the likely treatment benefits worth the
potential harms and costs?
Assuming that the study
conclusion is true ,would
it lead to a change in
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.
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.
Intention-to-treat Analysis: analyzed for according to
the groups for which they were originally assigned .
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
Compute the interquartile range for the sorted
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.