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Osteogenesis ImperfectaNCT03841188

Nutritional Interventional in Pediatric Patients With Osteogenesis Imperfecta

A study testing Nutritional orientation in people with Osteogenesis Imperfecta, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 19 years
Conditions the study is for
Osteogenesis Imperfecta
What is being tested?
Nutritional orientation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteBrazil
Study dates
8 Feb 2012to 10 Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Diagnosed with bone disorder

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-007

Other trials in Brazil

About this study

Official title: Calcium Intake Improvement After Nutritional Intervention in Pediatric Patients With Osteogenesis Imperfecta

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.

Read the 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.

Being tested
Nutritional orientation
Keywords
osteogenesis imperfecta, Nutritional intervention, calcium intake
Medical subject headings
Osteogenesis Imperfecta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional orientationOther

    Nutritional orientation with emphasis in rich calcium food

Study groups in NCT03841188
Study groupRoleWhat they receive
Nutritional OrientationOtherThe patients received a nutritional orientation with emphasis in food rich in calcium
Receives: Other: Nutritional orientation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calcium intake

    Was assessed using an food frequency questionaire adapted to calcium intake

    Measured: 12 months

Secondary outcomes (3)
  1. 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

    Measured: 12 months

  2. 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)

    Measured: 12 months

  3. Bone Mineral Density

    Bone mineral density was assessed thought Dual-energy X-ray absorptiometry

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start8 Feb 2012
  3. Primary completion20 May 2013
  4. Study completion10 Feb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841188
Sponsor's protocol ID
2011-0585
Status last verified
Jan 2019
First submitted
13 Feb 2019
Last updated
19 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional orientation in people with Osteogenesis Imperfecta, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calcium intake (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.

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