Calcium and Vitamin D Intakes in Children

Not Applicable

Completed

• Conditions: Hypocalcemia; Hypovitaminosis D
• Interventions: Dietary Supplement: Colecalcium supplement

• Registration Number: NCT01638494
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2012-06-29
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-09
• Last Update Submitted: 2012-07-09
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Colecalcium testing	Colecalcium supplement	administration of Colecalcium

Primary Outcome Measures

Name	Time	Method
Assessed VitD intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize VitD intake.	about 1 year	Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.

Secondary Outcome Measures

Name	Time	Method
Assessed Ca2 intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize Ca2 intake.	about 1 year	Evaluation and treatment of children with hypocalcemia and hypovitaminosis D.