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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
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 29, 2012
    Last Updated
    July 9, 2012
    Sponsor
    Federico II University
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    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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