Calcium and Vitamin D Intakes in Children
Primary Purpose
Hypocalcemia, Hypovitaminosis D
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Colecalcium supplement
Sponsored by
About this trial
This is an interventional treatment trial for Hypocalcemia focused on measuring 25-Hydroxyvitamin D, dietary counseling, pediatrics, allergy, bone metabolism
Eligibility Criteria
Inclusion Criteria:
- Ambulatory healthy subjects (male and female, age range 3-17 years) consecutively observed at our Department for routine clinical examination because vaccination program were considered eligible for the study.
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, genetic-metabolic disease, primitive bone disease, diabetes and endocrine disorder);
- and use of systemic steroids in the previous 3 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Colecalcium testing
Arm Description
administration of Colecalcium
Outcomes
Primary Outcome Measures
Assessed VitD intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize VitD intake.
Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.
Secondary Outcome Measures
Assessed Ca2 intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize Ca2 intake.
Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01638494
Brief Title
Calcium and Vitamin D Intakes in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Calcium (Ca2+) and vitamin D (VitD) play an important role in child health. Aims. The investigators evaluated the daily intake of Ca2+ and VitD in healthy children; and the efficacy of Ca2+ and VitD supplementation. Daily Ca2 + and VitD intake was evaluated in consecutive healthy children through a validated questionnaire. Subjects with a daily Ca2 + and VitD intake < 70% of dietary reference intakes (DRIs) were invited to participate in prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary counseling aiming to optimize daily Ca2+ and VitD intake plus administration of a commercially available Ca2 + and VitD supplementation product (Colecalcium®, Humana, Milan, Italy); group 2, dietary counseling alone. At the enrollment (T0) and after 4 months (T1) serum VitD levels were assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia, Hypovitaminosis D
Keywords
25-Hydroxyvitamin D, dietary counseling, pediatrics, allergy, bone metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colecalcium testing
Arm Type
Experimental
Arm Description
administration of Colecalcium
Intervention Type
Dietary Supplement
Intervention Name(s)
Colecalcium supplement
Intervention Description
Daily Ca2+ and VitD intake was determined using a previously validated written dietary questionnaire, filled by the parents with the help of a registered dietitian. Eventual assumption of Ca2+ and/or VitD supplements or fortified foods was also registered. All questionnaires were collected and analyzed using a specific software based on the Italian food composition tables (Winfood, Medimatica SRL, Martinsicuro, Teramo, Italy). All data were recorded in a specific clinical chart before statistical analysis. All subjects with less than 70% of the DRIs were invited to participate in a randomized trial aiming to investigate the efficacy of different nutritional interventions. The dietitian gave information to the parents on how to improve the consumption of foods rich in Ca2+ and VitD according to DRIs. No nutritional support products were prescribed in children enrolled in group 2.
Primary Outcome Measure Information:
Title
Assessed VitD intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize VitD intake.
Description
Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.
Time Frame
about 1 year
Secondary Outcome Measure Information:
Title
Assessed Ca2 intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize Ca2 intake.
Description
Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.
Time Frame
about 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ambulatory healthy subjects (male and female, age range 3-17 years) consecutively observed at our Department for routine clinical examination because vaccination program were considered eligible for the study.
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, genetic-metabolic disease, primitive bone disease, diabetes and endocrine disorder);
and use of systemic steroids in the previous 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani, MD, PhD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23702146
Citation
Cosenza L, Pezzella V, Nocerino R, Di Costanzo M, Coruzzo A, Passariello A, Leone L, Savoia M, Del Puente A, Esposito A, Terrin G, Berni Canani R. Calcium and vitamin D intakes in children: a randomized controlled trial. BMC Pediatr. 2013 May 23;13:86. doi: 10.1186/1471-2431-13-86.
Results Reference
derived
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Calcium and Vitamin D Intakes in Children
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