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Vitamin C Supplement for Lumbar Spine Surgery

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ClinicalTrials.gov Identifier: NCT03918694
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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.


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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 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

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




Primary Outcome Measures :
  1. Recruitment feasibility outcome [ Time Frame: up to 7 weeks ]
    The number of participants recruited and enrolled.

  2. Adherence feasibility outcome [ Time Frame: up to 7 weeks ]
    Calculate adherence in percentage as subjects enrolled versus completed

  3. 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

  4. Pain medication consumption [ Time Frame: up to 7 weeks ]
    Use of opioids and non-opioids analgesics documented in patients' health records

  5. Function [ Time Frame: up to 7 weeks ]
    Gait distance in feet will be obtained during physical therapy visit

  6. Would healing [ Time Frame: up to 7 weeks ]
    Surgical incision observation


Secondary Outcome Measures :
  1. Beck depression inventory [ Time Frame: up to 7 weeks ]
    A standard questionnaire with 1 - 40 points, 1=no depression and 40=extreme depression

  2. Vit C level [ Time Frame: up to 7 weeks ]
    Serum level of Vit C in umol/L

  3. 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

  4. 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

  5. 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

  6. 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

  7. Pain catastrophizing scale [ Time Frame: up to 7 weeks ]
    A standard scale to measure catastrophizing thoughts. Higher numbers indicate greater catastrophizing thoughts



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918694


Contacts
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Contact: Neena Sharma, PT, PhD, CMPT 913 588-4566 ext 4566 nsharma@kumc.edu

Locations
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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
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Principal Investigator: Neena Sharma, PT, PhD, CMPT University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03918694     History of Changes
Other Study ID Numbers: STUDY00143319
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents