EAL

CD: Nutritional Adequacy (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate compliance with diet in a group of adolescents with celiac disease and to estimate their nutritional choices in intake of energy, macronutrients, iron, calcium and fiber and frequency of consumption of food.

Inclusion Criteria:

Cases diagnosed with celiac disease according to ESPGHAN criteria.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Cases had been seen as outpatients at regular intervals at the Pediatric Clinic of Rome University. Controls were middle and high school students in Rome.

Design

Case-Control Study.

Blinding used (if applicable)

Not applicable.

Intervention (if applicable)

Gluten-free diet for adolescents with celiac disease.

Statistical Analysis

Statistical analysis was performed using Student's t test.

Data Collection Summary:

Timing of Measurements

Alimentary habits and diet composition were evaluated in adolescents with celiac disease and healthy controls.

Dependent Variables

Dietary intake measured through 3-day food records for energy, macronutrient composition, iron, calcium and fiber

Independent Variables

Gluten-free diet
Immunoglobulin A antigliadin and antiendomysium antibodies assessed for evaluation of compliance

Control Variables

Description of Actual Data Sample:

Initial N: 47 adolescents with celiac disease (10 males, 37 females), 47 healthy controls (13 males, 34 females)

Attrition (final N): 47 cases, 47 controls

Age: mean age cases: 15.2 +/- 2.3 years, mean age controls: 15.7 +/- 2.3 years

Ethnicity: not mentioned

Other relevant demographics:

Anthropometrics: Controls were matched for age

Location: Italy

Summary of Results:

	With Celiac Disease	Without Celiac Disease	P value	Italian Recommendations	American Recommendations
Calories - males	2166 +/- 563	2444 +/- 636	NS	2393 - 2976	2560
Calories - females	2039 +/- 529	2304 +/- 598	NS	1898 - 2338	2062
CHO (g)	253.9 +/- 72.6	292.6 +/- 84	<0.01
CHO (%)	45.9	48.4	<0.01	55 - 65	>50
Lipids (g)	94 +/- 27	102.6 +/- 29.4	NS
Lipids (%)	40.5	38.6	NS	30	<30
Protein (g)	75.8 +/- 21.7	87.3 +/- 24.9	<0.01
Protein (%)	13.5	15	<0.01	10	10
Iron (mg) - males	9.77 +/- 3.5	11 +/- 4	NS	12	12
Iron (mg) - females	11.5 +/- 4.11	12.4 +/- 4.8	NS	18	15
Calcium (mg)	725 +/- 357	755 +/- 372	NS	1200	1200
Fiber (g)	9.9 +/- 3.9	11.2 +/- 4.5	NS	30

Other Findings

Analysis of records and results of antibody levels showed that 25 subjects strictly followed dietetic prescriptions, whereas 22 patients consumed gluten-containing food.

There were no differences in sex, age, height or weight between those following a strict gluten-free diet and those consuming gluten.

Those with celiac disease and control subjects consumed a normocaloric diet.

Lipid and protein consumption was high, however, and the consumption of carbohydrates was low.

Dietary levels of calcium, fiber, and especially in girls, iron was low.

These nutritional imbalances were significantly more evident in those who strictly followed the gluten-free diet than in those consuming gluten, as a consequence of poor choices.

In those who strictly followed the gluten-free diet, overweight and obesity were more frequent (72%) than in those consuming gluten (51%) and in the control subjects (47%).

Author Conclusion:

In conclusion, our results show that, paradoxically, in adolescents with celiac disease, a strict gluten-free diet may be a nutritional risk factor, altering the already unbalanced diet commonly consumed by healthy adolescents, because it leads these subjects to incorrect alimentary choices. Although in past years there has been great improvement in diagnostic tools for celiac disease, we believe the movement has come to devote more attention to problems regarding a correct follow-up of celiac disease, not only the compliance with diet, but also the nutritional balance of the diet itself.

Funding Source:

University/Hospital:

Instituto di Pediatrica University

Reviewer Comments:

Inclusion/exclusion criteria not well described. Controls were not sex-matched.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		???
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	???
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	???
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	???
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		N/A
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes