Vitamin C Supplement for Lumbar Spine Surgery

Not Applicable

Completed

• Conditions: Lumbar Spine Surgery
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin C

• Registration Number: NCT03918694
• Lead Sponsor: University of Kansas Medical Center

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 Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-17
• Study Start: 2019-06-30
• Primary Completion: 2022-06-03
• Study Completion: 2022-06-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo tablets
Experimental	Vitamin C	Participants will receive Vit C tablets

Primary Outcome Measures

Name	Time	Method
Adherence feasibility outcome	up to 7 weeks	Calculate adherence in percentage as subjects enrolled versus completed
Function	up to 7 weeks	Gait distance in feet will be obtained during physical therapy visit
Would healing	up to 7 weeks	Surgical incision observation
Pain intensity: numeric rating pain scale	up to 7 weeks	self reported 0-10 numeric rating pain scale where 0=no pain and 10=most pain imagined
Pain medication consumption	up to 7 weeks	Use of opioids and non-opioids analgesics documented in patients' health records
Recruitment feasibility outcome	up to 7 weeks	The number of participants recruited and enrolled.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States