Calcium and Vitamin D Intakes in Children

Study Overview
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Brief Summary
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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
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Hypocalcemia, Hypovitaminosis D

Intervention / Treatment
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* Dietary Supplement: Colecalcium supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colecalcium testing<br>administration of Colecalcium | Dietary Supplement: Colecalcium supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessed VitD intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize VitD intake. | Evaluation and treatment of children with hypocalcemia and hypovitaminosis D. | about 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessed Ca2 intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize Ca2 intake. | Evaluation and treatment of children with hypocalcemia and hypovitaminosis D. | about 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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25-Hydroxyvitamin D, dietary counseling, pediatrics, allergy, bone metabolism