- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03841188
Nutritional Interventional in Pediatric Patients With Osteogenesis Imperfecta
Calcium Intake Improvement After Nutritional Intervention in Pediatric Patients With Osteogenesis Imperfecta
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
- Hospital de Clínicas de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients from zero to 19 years of patients seen at hospital.
- Diagnosed with osteogenesis imperfecta
Exclusion Criteria:
- Diagnosed with bone disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Nutritional Orientation
The patients received a nutritional orientation with emphasis in food rich in calcium
|
Nutritional orientation with emphasis in rich calcium food
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calcium intake
Time Frame: 12 months
|
Was assessed using an food frequency questionaire adapted to calcium intake
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consumption of glasses of milk
Time Frame: 12 months
|
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
|
12 months
|
Body mass index
Time Frame: 12 months
|
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)
|
12 months
|
Bone Mineral Density
Time Frame: 12 months
|
Bone mineral density was assessed thought Dual-energy X-ray absorptiometry
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elza D Mello, MD, PhD, Hospital de Clínicas de Porto Alegre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-0585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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