Vitamin C Supplement for Lumbar Spine Surgery

NCT ID: NCT03918694

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2022-06-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Lumbar Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups: placebo and Vitamin C
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Blinded pilot randomized control trial

Study Groups

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Experimental

Participants will receive Vit C tablets

Group Type ACTIVE_COMPARATOR

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

Daily use of Vit C tablets

Placebo

Participants will receive placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Daily use of placebo tablets

Interventions

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Vitamin C

Daily use of Vit C tablets

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily use of placebo tablets

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neena Sharma, PT, PhD, CMPT

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00143319

Identifier Type: -

Identifier Source: org_study_id

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