Vitamin C Supplement for Lumbar Spine Surgery

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Surgery
• Intervention / Treatment: Dietary supplement: Vitamin C; Dietary supplement: Placebo

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: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck depression inventory	A standard questionnaire with 1 - 40 points, 1=no depression and 40=extreme depression	up to 7 weeks
Vit C level	Serum level of Vit C in umol/L	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	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	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	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	up to 7 weeks
Pain catastrophizing scale	A standard scale to measure catastrophizing thoughts. Higher numbers indicate greater catastrophizing thoughts	up to 7 weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Neena Sharma, PT, PhD, CMPT, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Actual): June 3, 2022
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: STUDY00143319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No