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NCT05009498
Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery
NA trial testing Vitamin D3 supplementation in Vitamin D Deficiency in 240 participants. Status unknown.
1 August 2022
Quick facts
| Lead sponsor | Community Memorial Health System |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 September 2021 |
| Primary completion | 1 August 2022 |
| Estimated completion | 1 August 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Vitamin D3 supplementation
- Placebo
Conditions studied
- Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
- Rotator Cuff Tears — all drugs for Rotator Cuff Tears →
Sponsor
Community Memorial Health System
Who can join
Adults 18 to 65, any sex, with Vitamin D Deficiency or Rotator Cuff Tears. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rotator cuff injuries are the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Rotator cuff repair has long been the mainstay of treatment for symptomatic full-thickness tears and medium to large partial thickness tears that do no improve with nonoperative therapies. Approximately 32% of the US population is Vitamin D deficient. This is important for many health reasons, but specifically, Vitamin D has been found to play a critical role in bone mineralization and fracture healing/prevention. There is emerging data to support Vitamin D's role in regulating the inflammatory response throughout the body, which includes soft tissue (i.e. tendons) healing. The role of Vitamin D in tendon to bone healing has yet to be fully investigated, yet it is reasonable to conclude that normal blood levels of Vitamin D would optimize the setting for healing in rotator cuff repair. The investigators hypothesize that Vitamin D deficient patients undergoing shoulder rotator cuff repair will experience more positive outcomes and decreased complications when supplemented with Vitamin D3, compared to Vitamin D deficient patients who do not receive supplementation. The objective of this study is to demonstrate the positive effect of Vitamin D3 in rotator cuff repair healing and patient reported outcomes in patients who are Vitamin D deficient
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05009498
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Vitamin D3 supplementation
Trials testing the same drug.
- NCT02802722 — Does Vitamin D Supplementation Enhance Resolution of Inflammation After Community-acquired Pneumonia? · NA · completed
Other recruiting trials for Vitamin D Deficiency
Currently open trials in the same condition.
- NCT07317830 — Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults · NA · recruiting
- NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
- NCT07481240 — A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families · NA · recruiting
- NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting
- NCT07200011 — Effect of Vitamin D on the Clinical and Radiographic of Unsplinted Mandibular Implant Overdentures · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05009498 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Community Memorial Health System
- Last refreshed: 17 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05009498.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing