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Calcium and Vitamin D Intakes in Children

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ClinicalTrials.gov Identifier: NCT01638494
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

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.

Condition or disease Intervention/treatment Phase
Hypocalcemia Hypovitaminosis D Dietary Supplement: Colecalcium supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Colecalcium testing
administration of Colecalcium
Dietary Supplement: Colecalcium supplement
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 Measures :
  1. Assessed VitD intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize VitD intake. [ Time Frame: about 1 year ]
    Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.


Secondary Outcome Measures :
  1. Assessed Ca2 intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize Ca2 intake. [ Time Frame: about 1 year ]
    Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638494


Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Roberto Berni Canani, MD, PhD Federico II University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01638494    
Other Study ID Numbers: 56/09
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by Roberto Berni Canani, Federico II University:
25-Hydroxyvitamin D
dietary counseling
pediatrics
allergy
bone metabolism
Additional relevant MeSH terms:
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Rickets
Hypocalcemia
Avitaminosis
Vitamin D Deficiency
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases