Nutritional Interventional in Pediatric Patients With Osteogenesis Imperfecta

NCT03841188 | Completed

• 1 other identifier: 2011-0585
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: In several bone disorders, adequate calcium intake is a coadjuvant intervention to regular treatment. Osteogenesis imperfecta (OI) is a collagen disorder with a range of symptoms, ranging from fractures to minimum trauma, and is typically treated with bisphosphonates. This study aims evaluate the impact of a nutritional intervention (NI) on dietary calcium intake, bone mineral density (BMD)in pediatric patients with OI. METHODS: Interventional cohort study was designed with a NI. Dietary calcium intake, anthropometry and clinical feature was assessed at baseline including anthropometry, basal metabolic rate (BMR), BMD, Food guidance form was developed and sent to patients by mail. After 12 months, patients' clinical features were reassessed and compared with baseline data. RESULTS: Fifty-two children and adolescents were enrolled. A significant increase in total calcium intake (g), the percentage of adequate calcium intake (%), number of cups of milk ingested, were observed after NI. Was detected a positive correlation between the variation of BMD and milk consumption in patients treated with bisphosphonate. CONCLUSION: Was observed an increase in calcium intake in patients with OI. This finding demonstrates the importance of nutrition therapy as part of a multidisciplinary treatment approach for bone health.

Conditions

Osteogenesis Imperfecta

Keywords

osteogenesis imperfecta; Nutritional intervention; calcium intake

Outcome Measures

Primary Outcomes (1)

• Calcium intake

  Was assessed using an food frequency questionaire adapted to calcium intake

  12 months

Secondary Outcomes (3)

• Consumption of glasses of milk

  12 months

• Body mass index

  12 months

• Bone Mineral Density

  12 months

Study Arms (1)

Nutritional Orientation

OTHER

The patients received a nutritional orientation with emphasis in food rich in calcium

Other: Nutritional orientation

Interventions

Nutritional orientation OTHER

Nutritional orientation with emphasis in rich calcium food

Nutritional Orientation

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients from zero to 19 years of patients seen at hospital.
• Diagnosed with osteogenesis imperfecta

You may not qualify if:

• \- Diagnosed with bone disorder

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elza D Mello, MD, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: February 8, 2012
• Primary Completion: May 20, 2013
• Study Completion: February 10, 2014
• Last Updated: February 19, 2019

Record last verified: 2019-01

Locations

BR (1)