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Completed

NCT Number: NCT03918694

Vitamin C Supplement for Lumbar Spine Surgery

By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.

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Key information

Conditions

Lumbar Spine Surgery

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Dietary Supplement

Daily use of Vit C tablets

Placebo

Dietary Supplement

Daily use of placebo tablets

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Vitamin C Supplementation for Lumbar Spine Surgical Patients

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2019
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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