NCT01650883 is a NA clinical trial of Cholecalciferol in Vitamin D 25 OH Deficiency, sponsored by University of South Florida.

Who is sponsoring NCT01650883?

NCT01650883 is sponsored by University of South Florida.

What drugs are being tested in NCT01650883?

Interventions in NCT01650883: Cholecalciferol, Cholecalciferol 5,000 IU.

What condition does NCT01650883 study?

NCT01650883 studies Vitamin D 25 OH Deficiency.

Is NCT01650883 still recruiting?

NCT01650883 is currently completed. Last updated 25 July 2012.

Last reviewed 2012-07-25 · How we verify

NCT01650883

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients

Completed NA Last updated 25 July 2012

What this trial tests

NA trial testing Cholecalciferol in Vitamin D 25 OH Deficiency in 56 participants. Completed in 1 April 2011.

Timeline

1 March 2009

Primary endpoint
1 April 2011

1 April 2011

Quick facts

Lead sponsor	University of South Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	1 March 2009
Primary completion	1 April 2011
Estimated completion	1 April 2011
Sites	1 location across United States

Drugs / interventions tested

Cholecalciferol (cholecalciferol) — full drug profile →
Cholecalciferol 5,000 IU

Conditions studied

Vitamin D 25 OH Deficiency — all drugs for Vitamin D 25 OH Deficiency →

Sponsor

University of South Florida

Who can join

18 and older, any sex, with Vitamin D 25 OH Deficiency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The primary endpoint will be a direct comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a paired sample T-test by measuring the change in Vitamin D 25 OH from baseline to day 40 of treatment for both treatment groups.
Time frame: 40 days +/- 3 days

Sponsor's own description

The purpose of this study is to determine whether one of two Vitamin D3 (cholecalciferol) oral treatment regimens is superior to the other in normalizing Vitamin 25 OHD serum levels. While these two regimens in the end provide equal total dosing, the two arms differ in frequency and dosing during a 40 day treatment plan. The primary endpoint will be a direct comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a paired T-test. Secondary endpoints include record of adverse events throughout the 40 day study period as well as changes in basic laboratory values including CMP and ionized Calcium. The investigators hypothesize that the Cholecalciferol (Vitamin D3) daily dosing arm of 5000 IU daily will result in more efficient replacement as compared to the 50,000 IU dosing given every 10 days. Our goal will be to achieve a serum Vitamin 25 OH D level of \> 50 mg/dL at day 40. The investigators propose that 75% of the subjects on daily Vitamin D3 will achieve this level and that 35% of the subjects in the every 10 days dosing arm will reach this goal.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Cholecalciferol

Trials testing the same drug.

NCT06847373 — Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity · NA · recruiting
NCT06447441 — Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis · NA · not yet recruiting
NCT06301178 — Effect of Vitamin D Injection on Hypertrophic Scars and Keloids · Phase 1, PHASE2 · completed
NCT06053281 — The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy · EARLY_PHASE1 · unknown
NCT05860270 — Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis · Phase 4 · recruiting

Other University of South Florida trials

Trials by the same sponsor.

NCT07529366 — Pharmacist-Led Continuous Glucose Monitoring for Prediabetes · recruiting
NCT07342569 — The WeACT Program for Family Caregivers of People Living With Dementia · NA · not yet recruiting
NCT07502378 — Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic · Phase 4 · recruiting
NCT07241260 — Hydrate Heroes for Improving Brain Function & Mood · NA · not yet recruiting
NCT06377215 — Understanding Aided Speech Perception in Noise · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01650883 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of South Florida
Last refreshed: 25 July 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01650883.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing