25-Hydroxyvitamin D Pharmacokinetic Study

NCT03401541 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: H-37167
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetic parameters of orally administered 25-hydroxyvitamin D3 \[25(OH)D3\] and vitamin D3 from the corresponding serum concentration-time curves in healthy adults and adults with a history of intestinal malabsorption.

Conditions

Vitamin D Deficiency; Fat Malabsorption

Keywords

Calcifediol (25(OH)D); Calciferol (Vitamin D)

Outcome Measures

Primary Outcomes (2)

• Change in Serum vitamin D status

  The serum vitamin D status (pg/mL) will be determined at multiple time points secondary to receiving a single dose of either calciferol or calcifediol. We will obtain 11 time points after each drug administration which will allow us to observe the fluctuation in vitamin D status after receiving the study drug.

  2 weeks after administration

• Change in 25-Hydroxyvitamin D Status

  The serum 25(OH)D status (ng/mL) will be determined at multiple time points secondary to receiving a single dose of either calciferol or calcifediol. We will obtain 11 time points after each drug administration which will allow us to observe the fluctuation in 25(OH)D status after receiving the study drug.

  2 weeks after administration

Secondary Outcomes (5)

• Serum Calcium Levels

  Baseline and completion of each intervention period (2 weeks)

• Serum Phosphorus Levels

  Baseline and completion of each intervention period (2 weeks)

• Serum Albumin Levels

  Baseline and completion of each intervention period (2 weeks)

• Serum Creatinine levels

  Baseline and completion of each intervention period (2 weeks)

• Serum intact parathyroid hormone levels

  Baseline and completion of each intervention period (2 weeks)

Study Arms (4)

Fat-Mal, calcifediol then calciferol

EXPERIMENTAL

Participants with diagnosed fat malabsorption syndrome will initially receive one capsule of calcifediol for the first round of blood draws and then receive one capsule of calciferol for the second round.

Drug: Calcifediol; Drug: Calciferol

Fat-Mal, calciferol then calcifediol

EXPERIMENTAL

Participants with diagnosed fat malabsorption syndrome will initially receive one capsule of calciferol for the first round of blood draws and then receive one capsule of calcifediol for the second round.

Drug: Calcifediol; Drug: Calciferol

Non Fat-Mal, calcifediol then calciferol

EXPERIMENTAL

Participants that do not have a diagnosed fat malabsorption syndrome will initially receive one capsule of calcifediol for the first round of blood draws and thenreceive one capsule of calciferol for the second round.

Drug: Calcifediol; Drug: Calciferol

Non Fat-Mal, calciferol then calcifediol

EXPERIMENTAL

Participants that do not have a diagnosed fat malabsorption syndrome will initially receive one capsule of calciferol for the first round of blood draws and then receive one capsule of calcifediol for the second round.

Drug: Calcifediol; Drug: Calciferol

Interventions

Calcifediol DRUG

One capsule of 900 micrograms of 25(OH)D

Also known as: 25(OH)D

Fat-Mal, calcifediol then calciferol; Fat-Mal, calciferol then calcifediol; Non Fat-Mal, calcifediol then calciferol; Non Fat-Mal, calciferol then calcifediol

Calciferol DRUG

One capsule of 900 micrograms of Vitamin D

Also known as: Vitamin D

Fat-Mal, calcifediol then calciferol; Fat-Mal, calciferol then calcifediol; Non Fat-Mal, calcifediol then calciferol; Non Fat-Mal, calciferol then calcifediol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female with history of intestinal fat-malabsorption with confirmed diagnosis
• Taking vitamin D (ergocalciferol or cholecalciferol). Subjects taking vitamin D supplement of more than 2000 IUs (50 micrograms)/day) that may interfere with study endpoints must be willing and able to discontinue use of these supplements for the duration of the study and allow for at least a 14-day washout prior to prescreening and enrollment.
• Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline for each of the 2 pharmacokinetic studies.
• Serum total 25(OH)D \< 30 ng/mL

You may not qualify if:

• Unwilling to discontinue use of supplemental dose of vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol) daily equivalent (2,000 IU/50 μg) 1 week or less prior to randomization and during the study
• On medications that can affect vitamin D metabolism including steroids such as prednisone, anti-seizure medications and medications to treat HIV.
• Tanning in a tanning bed at least one week before the study and throughout the duration of this study.
• Anyone anticipating going on holiday (where exposure to sun is imminent) 1 week before or during the entire study.
• Participation in the study or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
• History of elevated serum calcium
• Chronic hepatic or renal failure
• Subjects with a history of an adverse reaction to orally administered vitamin D.
• Inability to give informed consent

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Solomon Carter Fuller Mental Health Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Charoenngam N, Kalajian TA, Shirvani A, Yoon GH, Desai S, McCarthy A, Apovian CM, Holick MF. A pilot-randomized, double-blind crossover trial to evaluate the pharmacokinetics of orally administered 25-hydroxyvitamin D3 and vitamin D3 in healthy adults with differing BMI and in adults with intestinal malabsorption. Am J Clin Nutr. 2021 Sep 1;114(3):1189-1199. doi: 10.1093/ajcn/nqab123.

  PMID: 34008842 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Calcifediol; Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Michael F Holick, MD, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each arm will first receive 25(OH)D and then vitamin D or vitamin D and then 25(OH)D

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 9 month and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by the current study principal investigators.

Locations

US (1)