免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Vitamin C Supplement for Lumbar Spine Surgery
Vitamin C Supplement for Lumbar Spine Surgery
Study Description
Brief Summary:
By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lumbar Spine Surgery | Dietary Supplement: Vitamin C Dietary Supplement: Placebo | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 2 groups: placebo and Vitamin C |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Masking Description: | Blinded pilot randomized control trial |
| Primary Purpose: | Treatment |
| Official Title: | Vitamin C Supplementation for Lumbar Spine Surgical Patients |
| Actual Study Start Date : | April 24, 2019 |
| Estimated Primary Completion Date : | January 2021 |
| Estimated Study Completion Date : | January 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Experimental
Participants will receive Vit C tablets
|
Dietary Supplement: Vitamin C
Daily use of Vit C tablets
|
|
Placebo Comparator: Placebo
Participants will receive placebo tablets
|
Dietary Supplement: Placebo
Daily use of placebo tablets
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Beck depression inventory [ Time Frame: up to 7 weeks ]A standard questionnaire with 1 - 40 points, 1=no depression and 40=extreme depression
- Vit C level [ Time Frame: up to 7 weeks ]Serum level of Vit C in umol/L
- Beck anxiety inventory [ Time Frame: up to 7 weeks ]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
- 2011 Fibromyalgia (FM) survey [ Time Frame: up to 7 weeks ]A standard questionnaire for centralized pain. Scores 3-6 in widespread pain index and 9 or greater in symptom severity suggest widespread pain
- fatigue questionnaire [ Time Frame: up to 7 weeks ]A standard questionnaire with 10 fatigue related questions. Each measured on 1-5 Likert scale. Higher numbers indicate greater fatigue
- Pittsburg sleep scale [ Time Frame: up to 7 weeks ]A standard questionnaires to examine sleep problems. A total of 5 scores or greater indicate poor sleep quality
- Pain catastrophizing scale [ Time Frame: up to 7 weeks ]A standard scale to measure catastrophizing thoughts. Higher numbers indicate greater catastrophizing thoughts
Eligibility Criteria
| Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients scheduled to have a lumbar spine fusion
- Can read and understand the English language
- BMI 35 or less
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Neena Sharma, PT, PhD, CMPT | 913 588-4566 ext 4566 | nsharma@kumc.edu |
Locations
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Neena Sharma, PT, PhD, CMPT | |
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
| Principal Investigator: | Neena Sharma, PT, PhD, CMPT | University of Kansas Medical Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 4, 2019 | ||||
| First Posted Date ICMJE | April 17, 2019 | ||||
| Last Update Posted Date | February 5, 2020 | ||||
| Actual Study Start Date ICMJE | April 24, 2019 | ||||
| Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vitamin C Supplement for Lumbar Spine Surgery | ||||
| Official Title ICMJE | Vitamin C Supplementation for Lumbar Spine Surgical Patients | ||||
| Brief Summary | 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 2 groups: placebo and Vitamin C Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Blinded pilot randomized control trial Primary Purpose: Treatment
|
||||
| Condition ICMJE | Lumbar Spine Surgery | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | January 2021 | ||||
| Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 45 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03918694 | ||||
| Other Study ID Numbers ICMJE | STUDY00143319 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | University of Kansas Medical Center | ||||
| Study Sponsor ICMJE | University of Kansas Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | University of Kansas Medical Center | ||||
| Verification Date | January 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
