Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients
Brief Summary: Patients requiring hemodialysis following kidney failure need a form of dialysis vascular access in order to undergo the dialysis procedure. Dialysis vascular access dysfunction is an enormous clinical problem. While the best form of vascular access is the arteriovenous fistula (AVF), its primary problem is early, aggressive cellular ingrowth that leads to poor maturation of the vessel, preventing its use for dialysis. Strategies to prevent AVF failure are needed.

Vitamin D is a hormone present in all human bodies and is important for good bone formation and immune function. There is new information that links vitamin D to the function of our veins and arteries, which are used in the creation of an arteriovenous fistulae. Our bodies can make vitamin D and can also get vitamin D from our diet. However, a majority of patients with chronic kidney disease and end-stage renal disease (ESRD) have low vitamin D levels (vitamin D deficiency). There are several benefits to correcting low vitamin D levels, however, it is not know whether correcting low vitamin D in the body will lead to better function of the vein and artery used for arteriovenous fistulae creation. The main goal of this pilot study is to examine the role of vitamin D supplementation on AVF maturation and useability for dialysis. Study results will be used to develop larger studies to examine the specific effect that vitamin D supplementation has on the vessels used for AVF creation and whether vitamin D promotes AVF maturation.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Cholecalciferol; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D3 | Intervention Type: DRUG; Name: Vitamin D3; Assigned to Arm(s): Cholecalciferol | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: PRT-201; Type: EXPERIMENTAL; Interventions: Drug: PRT-201 | Intervention Type: DRUG; Name: PRT-201; Assigned to Arm(s): PRT-201 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: control group; Type: NO_INTERVENTION; Interventions: Other: no intervention | Arm Label: Far infrared therapy; Type: EXPERIMENTAL; Interventions: Device: WSTM TY101 FIR emitter (Far infrared therapy) | Intervention Type: DEVICE; Name: WSTM TY101 FIR emitter (Far infrared therapy); Assigned to Arm(s): Far infrared therapy | Intervention Type: OTHER; Name: no intervention; Assigned to Arm(s): control group
D: Arm Label: PRT 201 (10 micrograms); Type: ACTIVE_COMPARATOR; Interventions: Drug: PRT-201 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: PRT-201 (30 micrograms); Type: ACTIVE_COMPARATOR; Interventions: Drug: PRT-201 | Intervention Type: DRUG; Name: PRT-201; Assigned to Arm(s): PRT 201 (10 micrograms) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: PRT-201; Assigned to Arm(s): PRT-201 (30 micrograms)

Answer: A