Vitamin D and Calcium Study

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Dietary Supplement: Vitamin D and Calcium

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00857831

B4162C-8

Details and patient eligibility

About

Vitamin D aids in the body's ability to absorb calcium, it is a vital component in bone formation and break down. Reduced levels of vitamin D can indicate a vitamin deficiency and may depress serum calcium levels. The following is a list of common causes of vitamin D deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight, individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver damage, and renal failure. Many of these factors can be found in individuals with spinal cord injury. SCI results in disuse bone loss after acute injury, which continues with duration of injury. The goal of this study is to determine the effects of vitamin D and calcium supplements on calcium metabolism and vitamin D deficiency in individuals undergoing functional electrical stimulation (FES) stand retraining (SRT).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Spinal Cord Injury (paraplegia or quadriplegia)
• Vitamin D deficiency
• Absolute deficient Vitamin D [25(OH)D] < 16 ng/ml
• Relative deficient Vitamin D [25(OH)D] <30ng/ml - participation in the FES/SRT study at Kessler Institute for Rehabilitation

Exclusion criteria

• History of kidney stones
• History of bone disorders
• Currently pregnant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Arm 1

Experimental group

Description:

Vitamin D & Calcium supplementation in FES

Treatment:

Dietary Supplement: Vitamin D and Calcium