Lumbar Spine SurgeryNCT03918694
Vitamin C Supplement for Lumbar Spine Surgery
A study testing Vitamin C in people with Lumbar Spine Surgery, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lumbar Spine Surgery
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2019to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to have a lumbar spine fusion
- Can read and understand the English language
- BMI 35 or less
Who cannot join
- 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
Show all 9Show fewer
- renal pathology
- sickle cell anemia
- iron metabolism disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Vitamin C Supplementation for Lumbar Spine Surgical Patients
By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.
Read the detailed description
Lumbar spine surgeries are common procedures for management of low back pain and their prevalence is increasing. However, their outcomes are less than optimal.
An effective and inexpensive solution to minimizing surgical complications and expediting recovery following lumbar spine surgery could be supplementation using high doses of vitamin C, also known as ascorbic acid. Vit C can help reduce oxidative stress and inflammation and improve immune system and body's own chemicals to fight pain.
The researchers want to examine if Vit C is effective in decreasing pain and pain medications and improving function. Gaining a better understanding of effects of Vit C on patient recovery may lead to improved outcomes.
- Conditions
- Lumbar Spine Surgery
- Being tested
- Vitamin C, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Daily use of Vit C tablets
PlaceboDietary supplement
Daily use of placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | Participants will receive Vit C tablets Receives: Dietary Supplement: Vitamin C |
| Placebo | Placebo comparator | Participants will receive placebo tablets Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility outcome
The number of participants recruited and enrolled.
Measured: up to 7 weeks
Adherence feasibility outcome
Calculate adherence in percentage as subjects enrolled versus completed
Measured: 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
Measured: up to 7 weeks
Pain medication consumption
Use of opioids and non-opioids analgesics documented in patients' health records
Measured: up to 7 weeks
Function
Gait distance in feet will be obtained during physical therapy visit
Measured: up to 7 weeks
Would healing
Surgical incision observation
Measured: up to 7 weeks
Secondary outcomes (7)
Beck depression inventory
A standard questionnaire with 1 - 40 points, 1=no depression and 40=extreme depression
Measured: up to 7 weeks
Vit C level
Serum level of Vit C in umol/L
Measured: up to 7 weeks
Beck anxiety inventory
A standard questionnaire with 21 questions. Scores 0-21=low anxiety, scores 22-35=moderate anxiety and scores 36 and above=potentially concerning level of anxiety
Measured: up to 7 weeks
2011 Fibromyalgia (FM) survey
A standard questionnaire for centralized pain. Scores 3-6 in widespread pain index and 9 or greater in symptom severity suggest widespread pain
Measured: up to 7 weeks
fatigue questionnaire
A standard questionnaire with 10 fatigue related questions. Each measured on 1-5 Likert scale. Higher numbers indicate greater fatigue
Measured: up to 7 weeks
Pittsburg sleep scale
A standard questionnaires to examine sleep problems. A total of 5 scores or greater indicate poor sleep quality
Measured: up to 7 weeks
Pain catastrophizing scale
A standard scale to measure catastrophizing thoughts. Higher numbers indicate greater catastrophizing thoughts
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start30 Jun 2019
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine SurgeryStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups: placebo and Vitamin C
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neena Sharma, PT, PhD, CMPT, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918694
- Sponsor's protocol ID
- STUDY00143319
- Status last verified
- May 2025
- First submitted
- 4 Jan 2019
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C Supplementation for Lumbar Spine Surgical Patients
- ClinicalTrials.gov ID
- NCT03918694
- Acronym / sponsor ID
- STUDY00143319
- Conditions
- Lumbar Spine Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.
Detailed description
Lumbar spine surgeries are common procedures for management of low back pain and their prevalence is increasing. However, their outcomes are less than optimal.
An effective and inexpensive solution to minimizing surgical complications and expediting recovery following lumbar spine surgery could be supplementation using high doses of vitamin C, also known as ascorbic acid. Vit C can help reduce oxidative stress and inflammation and improve immune system and body's own chemicals to fight pain.
The researchers want to examine if Vit C is effective in decreasing pain and pain medications and improving function. Gaining a better understanding of effects of Vit C on patient recovery may lead to improved outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups: placebo and Vitamin C
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Dietary Supplement: Vitamin CParticipants will receive Vit C tablets |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive placebo tablets |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to have a lumbar spine fusion
- Can read and understand the English language
- BMI 35 or less
Key exclusion criteria (9 listed)
- Patients taking certain medications
- lumbar spine laminectomy or discectomy
- taking a Vit C supplement
- pregnancy
- Cauda equine syndrome or spinal tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CDaily use of Vit C tablets | Dietary supplement | Experimental |
| PlaceboDaily use of placebo tablets | Dietary supplement | Placebo |
Primary outcome
Recruitment feasibility outcome
Time frame: up to 7 weeks
The number of participants recruited and enrolled.
Adherence feasibility outcome
Time frame: up to 7 weeks
Calculate adherence in percentage as subjects enrolled versus completed
Pain intensity: numeric rating pain scale
Time frame: up to 7 weeks
self reported 0-10 numeric rating pain scale where 0=no pain and 10=most pain imagined
Pain medication consumption
Time frame: up to 7 weeks
Use of opioids and non-opioids analgesics documented in patients' health records
Function
Time frame: up to 7 weeks
Gait distance in feet will be obtained during physical therapy visit
Would healing
Time frame: up to 7 weeks
Surgical incision observation
7 secondary outcomes
Beck depression inventory
Time frame: up to 7 weeks
Vit C level
Time frame: up to 7 weeks
Beck anxiety inventory
Time frame: up to 7 weeks
2011 Fibromyalgia (FM) survey
Time frame: up to 7 weeks
fatigue questionnaire
Time frame: up to 7 weeks
Pittsburg sleep scale
Time frame: up to 7 weeks
Pain catastrophizing scale
Time frame: up to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neena Sharma, PT, PhD, CMPT principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Lumbar Spine Surgery, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility outcome (time frame: up to 7 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.