Vitamin C Supplement for Lumbar Spine Surgery
Vitamin C Supplementation for Lumbar Spine Surgical Patients
1 other identifier
interventional
55
1 country
1
Brief Summary
By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
June 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2022
CompletedMay 15, 2025
May 1, 2025
2.9 years
January 4, 2019
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Recruitment feasibility outcome
The number of participants recruited and enrolled.
up to 7 weeks
Adherence feasibility outcome
Calculate adherence in percentage as subjects enrolled versus completed
up to 7 weeks
Pain intensity: numeric rating pain scale
self reported 0-10 numeric rating pain scale where 0=no pain and 10=most pain imagined
up to 7 weeks
Pain medication consumption
Use of opioids and non-opioids analgesics documented in patients' health records
up to 7 weeks
Function
Gait distance in feet will be obtained during physical therapy visit
up to 7 weeks
Would healing
Surgical incision observation
up to 7 weeks
Secondary Outcomes (7)
Beck depression inventory
up to 7 weeks
Vit C level
up to 7 weeks
Beck anxiety inventory
up to 7 weeks
2011 Fibromyalgia (FM) survey
up to 7 weeks
fatigue questionnaire
up to 7 weeks
- +2 more secondary outcomes
Study Arms (2)
Experimental
ACTIVE COMPARATORParticipants will receive Vit C tablets
Placebo
PLACEBO COMPARATORParticipants will receive placebo tablets
Interventions
Eligibility Criteria
You may qualify if:
- Patients scheduled to have a lumbar spine fusion
- Can read and understand the English language
- BMI 35 or less
You may not qualify if:
- Patients taking certain medications
- lumbar spine laminectomy or discectomy
- taking a Vit C supplement
- pregnancy
- Cauda equine syndrome or spinal tumor
- neurological, neurodegenerative or cognitive issues
- renal pathology
- sickle cell anemia
- iron metabolism disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neena Sharma, PT, PhD, CMPT
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Blinded pilot randomized control trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2019
First Posted
April 17, 2019
Study Start
June 30, 2019
Primary Completion
June 3, 2022
Study Completion
June 3, 2022
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share