Nutritional Interventional in Pediatric Patients With Osteogenesis Imperfecta
Primary Purpose
Osteogenesis Imperfecta
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nutritional orientation
Sponsored by
About this trial
This is an interventional supportive care trial for Osteogenesis Imperfecta focused on measuring osteogenesis imperfecta, Nutritional intervention, calcium intake
Eligibility Criteria
Inclusion Criteria:
- Patients from zero to 19 years of patients seen at hospital.
- Diagnosed with osteogenesis imperfecta
Exclusion Criteria:
- Diagnosed with bone disorder
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nutritional Orientation
Arm Description
The patients received a nutritional orientation with emphasis in food rich in calcium
Outcomes
Primary Outcome Measures
Calcium intake
Was assessed using an food frequency questionaire adapted to calcium intake
Secondary Outcome Measures
Consumption of glasses of milk
Evaluated according to quantity and frequency (For milk, 0 = does not consume, 1 = consume < 1 cup per day, 2 = consume 1 to 2 cups/day, and 3 = consume 3 or more cups of milk/day
Body mass index
Calculation divides an children's weight in kilograms by their height in metres squared.Evaluated according to the z-score proposed by the WHO (2006, 2007)
Bone Mineral Density
Bone mineral density was assessed thought Dual-energy X-ray absorptiometry
Full Information
NCT ID
NCT03841188
First Posted
February 13, 2019
Last Updated
February 15, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03841188
Brief Title
Nutritional Interventional in Pediatric Patients With Osteogenesis Imperfecta
Official Title
Calcium Intake Improvement After Nutritional Intervention in Pediatric Patients With Osteogenesis Imperfecta
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2012 (Actual)
Primary Completion Date
May 20, 2013 (Actual)
Study Completion Date
February 10, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Nutrition Intervention NI was performed at three nutritional visits (baseline, 6 and 12 months). Clinical features were evaluated at baseline, including anthropometric measurements, basal metabolic rate (BMR), BMD An indirect calorimetry test was performed to estimate the BMR of each participant. Dietary intake was assessed using daily food intake report completed by participants on three non-consecutive days. The frequency of consumption and amount of calcium intake were evaluated using a food frequency questionaire (FFQ) with emphasis on foods rich in calcium. Based on these data, the nutritional needs for each subject were calculated, and personalized food guidance (including recipes rich in calcium) was delivered by mail.
In the second visit, at 6 months after baseline, adaptations were made to food guidance according to the needs of each patient, doubts about feeding were clarified and the importance of a diet rich in calcium was reinforced.
On the third visit, at 12 months after baseline, dietary calcium intake, anthropometric measurements, , BMD were re-evaluated.
Calcium Intake Calcium intake was assessed using an FFQ adapted to calcium intake applied before and after the NI. In the present study, the focus was on the consumption of foods high in calcium, such as milk, yogurt, and cheese. To establish the percentage of the adequacy of intake, the values obtained from the FFQ were compared with the Estimated Average Requirement (EAD) and Recommended Dietary Allowances (RDA).
The FFQ for calcium intake was composed of milk (1 cup = 175 ml), 1 yogurt (120 ml), and cheese (1 medium slice = 30 g). These foods were classified according to the consumer (as D, daily; W, weekly, and M, monthly) and indicating the number of times (1 to 10) and the size of the corresponding portion, if greater, equal or less than the given portion (according to a poster with color photos to illustrate the portion size of each food source of calcium).
Consumption of glasses of milk and soda were also evaluated according to quantity and frequency (For milk, 0 = does not consume, 1 = consume < 1 cup per day, 2 = consume 1 to 2 cups/day, and 3 = consume 3 or more cups of milk/day; for soda, 1 = consume daily, 2 = consume only on weekends or 2 times/week, 3 = consumes less than 1 day/week, and 4 = does not consume).
Clinical Data Clinical data were obtained during the enrollment and included age, gender, OI type, use of bisphosphonates, and calcium intake.
Anthropometric Data and Basal Metabolic Rate Anthropometric measurements (weight and height) were measured and evaluated according to the z-score proposed by the World Health Organization WHO. The length was measured in the supine position in children smaller than 1 m and children could not remain in the standing position. Patients over 1.04 m and unable to remain standing were measured in the supine position. BMI was calculated according to the WHO. The BMR was evaluated through indirect calorimetry and the data was published previously.
Bone Mineral Density BMD was determined before and after the intervention using Dual Energy X-Ray Absorptiometry (DEXA) on a Lunar DXA (GE Healthcare, San Francisco, USA). Bone mineral content (BMC) (g), lumbar spine BMD (L1-L4), and total body BMC (TB) were calculated and expressed as z-scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
Keywords
osteogenesis imperfecta, Nutritional intervention, calcium intake
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional Orientation
Arm Type
Other
Arm Description
The patients received a nutritional orientation with emphasis in food rich in calcium
Intervention Type
Other
Intervention Name(s)
Nutritional orientation
Intervention Description
Nutritional orientation with emphasis in rich calcium food
Primary Outcome Measure Information:
Title
Calcium intake
Description
Was assessed using an food frequency questionaire adapted to calcium intake
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Consumption of glasses of milk
Description
Evaluated according to quantity and frequency (For milk, 0 = does not consume, 1 = consume < 1 cup per day, 2 = consume 1 to 2 cups/day, and 3 = consume 3 or more cups of milk/day
Time Frame
12 months
Title
Body mass index
Description
Calculation divides an children's weight in kilograms by their height in metres squared.Evaluated according to the z-score proposed by the WHO (2006, 2007)
Time Frame
12 months
Title
Bone Mineral Density
Description
Bone mineral density was assessed thought Dual-energy X-ray absorptiometry
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients from zero to 19 years of patients seen at hospital.
Diagnosed with osteogenesis imperfecta
Exclusion Criteria:
- Diagnosed with bone disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elza D Mello, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-007
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Nutritional Interventional in Pediatric Patients With Osteogenesis Imperfecta
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