osteogenesis imperfecta
Conditions
Interventions
As previously randomized, 28 participants were allocated to either the experimental group (Vitamin C) and 26 the control group (Placebo) and were given oral administration of vitamin C or placebo at a
Dietary supplement
D26.660
Sponsors
Universidade do Sul de Santa Catarina
Universidade do Sul de Santa Catarina
Eligibility
Age
0 Months to 18 Years
Inclusion criteria
Inclusion criteria: Patients with OI (types I, III and IV) and without other associated diseases. Age range from zero to 18 years. Patients who underwent intravenous disodium pamidronate treatment cycles at the HIJG every 2, 3, 4, or 6 months between January and December 2018. Patients who had conditions for oral medication administration. Patients who do not use continuous analgesics, continuous anti-inflammatory drugs or antidepressants for pain control or other medical indication.
Exclusion criteria
Exclusion criteria: PParticipants who did not attend the hospital for disodium pamidronate administration. Participants who presented temporary or permanent suspension of disodium pamidronate administration during the data collection period. Participants who did not have blood samples collected during the first or second data collection. Participants who did not return for the second data collection. Participants who used continuous analgesics, continuous anti-inflammatory drugs and antidepressants for pain control or other medical indication after the first data collection. Participants reporting inadequate vitamin C supplementation between data collections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: At least 30% reduction in pain intensity, as assessed by the FLACC scale(Face, Legs, Activity, Crying, and Consolability), FPS-R (Face pain Scale - Revised), and APPT (Adolescent and Pediatric Pain Tool) in OI patients using disodium pamidronate supplemented with vitamin C compared to the placebo group.;Outcome Found 1: Prior to placebo or vitamin C supplementation, one adolescent (3.22%, OI type III) reported bilateral pain in the lower back and buttock. The instrument used to evaluate this participant was the APPT, which measures not only the location of pain, but also its quality and intensity. The intensity reported by the patient was “too much pain” and the pain quality descriptors had characteristics: emotional (bad pain), sensory (stabbing) and temporal (coming suddenly and starting slowly). This same participant, after being supplemented with placebo for six months, reported right leg pain. The intensity was “average pain” and the descriptors had characteristics: emotional (pain that bothers and painful) and temporal (always the same pain). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome Found 4: There was no statistically significant increase in IL-4 concentration between Placebo and Vitamin C groups after supplementation. However, IL-10 concentrations increased significantly in the Vitamin C group compared to the placebo group after supplementation.;Outcome Found 5: Increased concentrations of hydroxyproline were found after supplementation in the Vitamin C group compared to the Placebo group.;Quality of life improvement, assessed using the PedsQL TM Infant Scales (PedsQL - Pediatric Quality of Life Inventory - Children's Questionnaire) and the PedsQL TM 4.0 Generic Core Scales (PedsQL - Pediatric Quality of Life Questionnaire) in OI patients on disodium pamidronate supplemented with vitamin C compared to the placebo group.;Reduction in the number of fractures, as assessed by the number of fractures in OI patients using disodium pamidronate supplemented with vitamin C compared to the placebo group.;Reduction in serum levels of proinflammatory cytokines TNF, IL-1beta, IL-6, MMP-9 and TGF-beta 1, as measured by Enzyme Immunosorbent Assay (ELISA) in patients with OI using disodium pamidronate supplemented with vitamin C compared to placebo group.;Increased serum levels of anti-inflammatory cytokines IL-4 and IL-10, as measured by Enzyme Immunosorbent Assay (ELISA) in patients with OI using disodium pamidronate supplemented with vitamin C compared to placebo group.;Increased serum hydroxyproline levels as measured by colorimetric biochemical assay in patients with OI using disodium pamidronate supplemented with vitamin C compared to placebo group.;Outcome Found 1: The children's quality of life score as well as the children's quality of life score through their parents 'or guardians' perceptions were similar in the Placebo and Vitamin C groups, both pre- and post-intervention.;Outcome Found 2: The number of post-intervention fractures was similar in Placebo and Vitamin C individuals. ;Outcome Found 3: There was no statistically significant dec | — |
Countries
Brazil
Contacts
Public ContactCinthia Faraco Martinez Cebrian
Hospital Infantil Joana de Gusmão
Outcome results
None listed