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Effect of vitamin D3 supplementation in participants with periodontitis and vitamin D deficiency: A randomized, interventional, parallel, placebo-controlled, double blind clinical trial.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503671-16-00
Acronym
D-CURE-IV-22-1
Enrollment
82
Registered
2023-12-05
Start date
2023-12-15
Completion date
Unknown
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Brief summary

Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm.

Detailed description

Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean probing pocket depth (PPD)., Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean clinical attachment level (CAL)., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 4mm, Absolute change from baseline (V2) to week 12 (V3) in the number of residual PPD ≥ 5mm., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 6mm, Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the bleeding on probing (BoP), Absolute change from baseline to week 12 (V3) and 24 (V4) on the plaque control (O’Leary), Percentage of participants with ≤4 sites with PPD ≥ 5mm at week 24 (V4), Absolute change from baseline (V1) to week 12 (V3) and 24 (V4) in the 25(OH)D3 serum concentration., Percentage of participants reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 24 (V4)., Incidence in adverse events including adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs)., Change from baseline in laboratory data including the assessment of serum concentration of calcium and phosphate throughout the clinical trial.

Interventions

DRUGD-CURE 25000 UI gélules.
DRUGPlacebo of vitamin D

Sponsors

Laboratoires S.M.B.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm.

Secondary

MeasureTime frame
Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean probing pocket depth (PPD)., Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean clinical attachment level (CAL)., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 4mm, Absolute change from baseline (V2) to week 12 (V3) in the number of residual PPD ≥ 5mm., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 6mm, Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the bleeding on probing (BoP), Absolute change from baseline to week 12 (V3) and 24 (V4) on the plaque control (O’Leary), Percentage of participants with ≤4 sites with PPD ≥ 5mm at week 24 (V4), Absolute change from baseline (V1) to week 12 (V3) and 24 (V4) in the 25(OH)D3 serum concentration., Percentage of participants reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 24 (V4)., Incidence in adverse

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026