To determine if a one-time oral administration of ergocalciferol results in a decline in plasma mucin-1 levels in healthy individuals and individuals with ADTKD-MUC1.
This is a pilot, open-labelled, to determine if oral administration of a single dose of ergocalciferol lowers plasma mucin-1 levels. The study population will include 40 healthy individuals and 40 individuals with ADTKD-MUC1. The study consists of an initial screening, signing of consent of interested individuals, performance of pregnancy test in women of child-bearing age and screening labs, and administration of 200,000 units of ergocalciferol on Day 0 (On Study). Laboratory studies will be performed at baseline, on Days 3, 7, and 10.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Plasma mucin-1 levels
Plasma mucin-1 levels will be measured in both groups. using a two-tailed T-test.
Time frame: Baseline
Plasma mucin-1 levels
Plasma mucin-1 levels will be measured in both groups. using a two-tailed T-test.
Time frame: 3 days
Plasma mucin-1 levels
Plasma mucin-1 levels will be measured in will be measured in both groups.
Time frame: 7 days
Plasma mucin-1 levels
Plasma mucin-1 levels will be measured in will be measured in both groups.
Time frame: 10 days
Urinary mucin-1 levels in healthy controls
Urinary mucin-1 levels
Time frame: Baseline
Urinary mucin-1 levels in healthy controls
Urinary mucin-1 levels
Time frame: 3 days
Urinary mucin-1 levels in healthy controls
Urinary mucin-1 levels
Time frame: 7 days
Urinary mucin-1 levels in healthy controls
Urinary mucin-1 levels
Time frame: 10 days
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