EAL

CD: Nutritional Adequacy (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To analyze the changes in body composition in children with celiac disease at diagnosis and 1 year after gluten-free diet.

Inclusion Criteria:

Celiac disease diagnosed according to ESPGAN criteria.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Children admitted to the Dept of Pediatrics, Second University of Naples, Italy from January 1992 - December 1994.

Design

Case-Control Study.

Blinding used (if applicable)

No blinding used.

Intervention (if applicable)

Gluten-free diet for 1 year.

Statistical Analysis

Differences between mean values statistically assessed by the paired Student's t test. The relationship between the series of values was studied by the Spearman test.

Data Collection Summary:

Timing of Measurements

Nutritional and bone mineral status assessment included anthropometry, blood chemistry, single beam photonic absorptiometry, and 24-hour dietary intake recall at diagnosis and 1 year after gluten-free diet. Patients with iron deficiency received iron supplementation and 1000 IU/day Vitamin D2.

Dependent Variables

Body weight measured by counterweight scale
Height measured through stadiometer and Wunder infantometer
Triceps and subscapular skinfolds measured by Lange skinfold caliper
Midarm muscle circumference measured through measuring tape
Blood samples taken on morning of anthropometric assessment and worked up for hemoglobin, iron, transferrin, serum protein, albumin, zinc, cholesterol, triglycerides, calcium, phosphorus, and alkaline phosphatase
Bone mineral content evaluated by single beam photonic absorptiometry on the radius shaft of the nondominant arm at 1/3 forearm length proximal to the ulnar styloid

Independent Variables

Dietary intake assessed through 24-hour dietary recall through visual memory system with parents and nutritonally analyzed. Gluten-free diet compliance verified by assessing circulating antigliadin antibodies during the follow-up.

Description of Actual Data Sample:

Initial N: 23 celiac children, 8 boys and 15 girls, healthy age- and sex-matched controls.

Attrition (final N): 23 celiac children and 23 controls

Age: mean 4.7 +/- 0.76 years, range 1 - 12 years

Ethnicity: Not mentioned.

Other relevant demographics: Symptomatic period before diagnosis was mean 7.95 +/- 2.5 months (1 - 12 months).

Anthropometrics: Controls were age and sex matched.

Location: Italy

Summary of Results:

Anthropometric, Biochemistry and Bone Densitometry Data

	Controls	P value	At Diagnosis	P value for 1 year change	After 1 Year GFD	1 year P value vs controls
Height	0.58+/- 0.2	0.00006	-1.03 +/- 0.2	0.00002	-0.2 +/- 0.2	0.01
Bone Mineral Content	0.28 +/- 0.2	0.004	-0.76 +/- 0.3	0.007	-0.05 +/- 0.1	NS
Arm Muscle Area	0.43 +/- 0.2	0.0003	-0.8 +/- 0.2	0.005	-0.13 +/- 0.2	0.07
BMI	0.54 +/- 0.2	NS	-0.003 +/- 0.2	0.0007	0.9 +/- 0.2	NS
Triceps Skinfold	-0.11 +/- 0.2	0.0004	-0.99 +/- 0.1	0.000006	-0.4 +/- 0.1	NS
Subscapular Skinfold	0.51 +/- 0.2	0.002	-0.17 +/- 0.1	0.0008	0.4 +/-0.1	NS
Fat Area Index	-0.19 +/- 0.2	0.00001	-1.1 +/- 0.1	0.0001	-0.45 +/- 0.1	NS
Weight for Height Index	104 +/- 3	NS	99 +/- 2	0.0001	110 +/- 2	NS
Hemoglobin			11.1 +/- 0.4	0.001	12.6 +/- 0.2
Iron			43 +/- 7	0.01	67 +/- 5
Transferrin			360 +/- 15	NS	341 +/- 13
Protein			6.8 +/- 0.1	0.0004	7.4 +/- 0.1
Albumin			4.3 +/- 0.07	0.001	4.7 +/- 0.06
Triglycerides			94.4 +/- 7.8	0.004	68.1 +/- 7
Cholesterol			145 +/- 9	NS	165 +/- 8
Calcium			9.7 +/- 0.2	0.007	10.3 +/- 0.2
Phosphorus			5.1 +/- 0.2	NS	4.9 +/- 0.1
Alkaline Phosphatase			537 +/- 52	NS	600 +/- 3
Zinc			62 +/- 5	0.00003	89.9 +/- 4

Other Findings

At diagnosis the patients had height, arm muscle area, triceps skinfolds, subscapular skinfolds, fat area index, and bone mineral content significantly lower than in an age- and sex-matched control group. All parameters significantly rose during the study.

After 1 year on gluten-free diet, no significant difference was found between patients and controls in all the parameters studied except in height and arm muscle area, which, however, were very near to the normal expected.

Serum hemoglobin, iron and zinc values were below the normal range in more than 50% of patients at diagnosis and within normal ranges in almost all of them after 1 year of gluten-free diet. Serum hemoglobin, iron, zinc, triglycerides, proteins, albumin and calcium values significantly rose during the year of gluten-free diet.

Author Conclusion:

On the whole, anthropometry and biochemistry as well as bone densitometry clearly reveal malnutrition in our patients at diagnosis and a complete recovery after 1 year of gluten-free diet. The malnutrition at diagnosis concerns circulating and storage fats and proteins as well as iron, zinc and bone mineral content. This is in contrast with findings in adult celiac disease. It is likely that the growing body has a rapid and more effective capacity to restore lost stores on recovery from malnutrition.

Funding Source:

University/Hospital:

Second University of Naples

Reviewer Comments:

Authors note that small sample size and lack of homogeneity in subject age may affect study results. Compliance to gluten-free diet was monitored.

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?		Yes
	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?	Yes
	2.2.	Were criteria applied equally to all study groups?	N/A
	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?	Yes
3.	Were study groups comparable?		Yes
	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?	N/A
	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.)	N/A
	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?	Yes
	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?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	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?	N/A
	7.7.	Were the measurements conducted consistently across groups?	N/A
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?	Yes
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