NCT03162406

Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis

Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis: A Randomized Double-blinded Placebo Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The subjects participating in the trial will be randomly allocated to either the group receiving the treatment under investigation (scaling and root planning (SRP) accompanied by administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction with placebo) as the control. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins. After randomization, the two groups of subjects will be followed in exactly the same way and the only differences between them will be the vitamin D/placebo that they will receive.

Detailed description

It is likely that a chronically low intake of vitamin D and calcium may lead to a negative calcium balance, thus causing a secondary increase in calcium removal from bone, including the alveolar bone. Such bone loss may contribute to weakening of the tooth-attachment apparatus. In addition to its action on skeletal homeostasis, vitamin D, and, in particular, its hormonally active form, 1a,25-dihydroxyvitamin D, has anti-inflammatory and antimicrobial effects via modulation of inflammatory cytokine production by immune cells and stimulated secretion of peptides with antibacterial action by cells of the monocyte-macrophage lineage.These multiple actions of vitamin D are potentially appealing for the management of patients with periodontal disease, whose pathogenesis is based on chronic bacterial-driven inflammation. Excess of vitamin D leads to a disturbance of the calcium in the body cycle. The symptoms experienced are: weakness, fatigue, headache, nausea, vomiting, diarrhea, polyuria, calciuria, dry mouth, nighttime urination, proteinuria, increased thirst, loss ofappetite, dizziness. In case of high blood calcium level for a prolonged period, calcium deposits (tissue calcinosis) may occur in the soft tissues, including the kidneys where they cause calculations and calcium deposits in the nephrons, blood vessels, heart, lung and skin. These effects are reversible if the intoxication is detected in time.

Conditions

• Generalized Chronic Periodontitis
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3	Oral supplementation 25000 IU once per week for 6 months
DIETARY_SUPPLEMENT	Placebo	Oral supplementation once per week for 6 months

Timeline

• Start date: 2017-05-18
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-05-22
• Last updated: 2017-05-23

Locations

1 site across 1 country: Belgium