Calcium and Vitamin D Intakes in Children

NCT ID: NCT01638494

Last Updated: 2012-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-02-28

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.

Conditions

Hypocalcemia; Hypovitaminosis D

Keywords

25-Hydroxyvitamin D; dietary counseling; pediatrics; allergy; bone metabolism

Study Design

• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colecalcium testing

administration of Colecalcium

Group Type: EXPERIMENTAL

Colecalcium supplement

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Berni Canani, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

References

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.

Reference Type: DERIVED

PMID: 23702146 (View on PubMed)

Other Identifiers

56/09

Identifier Type: -

Identifier Source: org_study_id