Calcium and Vitamin D Intakes in Children

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

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

Federico II University

Investigators

• Principal Investigator: Roberto Berni Canani, MD, PhD; Federico II University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

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