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
|Condition or disease||Intervention/treatment||Phase|
|Hypocalcemia Hypovitaminosis D||Dietary Supplement: Colecalcium supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
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.
- 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.
- 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.
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
|Principal Investigator:||Roberto Berni Canani, MD, PhD||Federico II University|