CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6 enrolled
Drug / intervention
Vitamin D +2 moredrug
Likely dose
Vitamin D 2000IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05008484
NCT05008484Phase 3Completed

Effects of Electrical Stimulation and Vitamin D Supplementation on Bone Health Following Spinal Cord Injury

VA Office of Research and Development·interventional·Posted Aug 17, 2021·Updated Jan 23, 2026

In Brief

A Phase 3 clinical trial evaluating NMES, Vitamin D, and 1 other intervention for Spinal Cord Injury. Completed, enrolled 6 participants across 1 site.

Detailed Summary

Neurogenic osteoporosis is a common complication of spinal cord injury (SCI) that is associated with low impact bone fractures. It is concerning that more than 46,000 Veterans affected with SCI and are at risk of osteoporosis and possible low impact fractures. About fifty percent of all individuals with SCI will develop low impact fracture in their life time. The management of osteoporosis-related fractures can impose substantial economic burden on the health care system, the individual and the families. Previous studies did not succeed in reversing the process of bone loss after SCI. In the present pilot study, we will evaluate the effect of Neuromuscular Electrical Stimulation Resistance Training in combination with oral Vitamin D supplementation, on bone quality in Veterans with chronic SCI, using a randomized experimental design.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedAug 17, 2021
Enrollment StartOct 1, 2021
Primary CompletionJun 13, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.9 years ago

Interventions

NMESdevice

Subjects will undergo 4.5 months of open kinematic chain resistance training followed by 4.5 months of closed kinematic chain using simple rowing approach

Vitamin Ddrug

2000IU oral vitamin D supplementation daily for 9 months

Passive movementbehavioral

Subjects will perform simple passive movement exercise for their legs while sitting in their wheelchairs at their home. The frequency of the training will be twice weekly