Gene Expression, Metabolomic, Microbiome, and Calcium Metabolism in Response to Varied Vitamin D Dosages

NCT02856776 | Completed DMC

• 1 other identifier: H-35506
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

There continues to be debate as to how much vitamin D an adult requires to be vitamin D sufficient. A multitude of association studies have suggested that improving serum 25(OH)D \>30 ng/mL may reduce risk of many chronic illnesses and improve immune function. The aim of this study is to define dynamic changes in PTH, broad gene expression in circulating immune cells, metabolomics, and microbiome profile in response to varying doses of vitamin D supplementation.

Conditions

Vitamin D Insufficiency

Keywords

Vitamin D; Metabolomics; Microbiota; Gene Expression

Outcome Measures

Primary Outcomes (6)

• Change in Gene Expression in circulating immune cells

  Change in gene expression of VDR receptors located on circulating immune cells.

  Baseline and 24 weeks

• Change in Metabolomic profile - Carbohydrates

  Change in carbohydrate profile of blood and urine i.e. Glucose (mg/dL)

  Baseline and 24 weeks

• Change in Stool microbiome

  Change in microbiota of the stool

  Baseline and 24 weeks

• Change in Metabolomic profile - Amino Acids

  Change in amino acid profile of blood and urine i.e. Lysine (mg/dL)

  Baseline and 24 weeks

• Change in Metabolomic profile - Small Peptides

  Change in small peptide profile of blood and urine i.e. stearic acid (mg/dL)

  Baseline and 24 weeks

• Change in Metabolomic profile - Lipids

  Change in lipid profile of blood and urine i.e. cholesterol (mg/dL)

  Baseline and 24 weeks

Study Arms (4)

Arm 1: 600 IU vitamin D

EXPERIMENTAL

Subject will receive 600 IUs of vitamin D3/day for 24 weeks.

Dietary Supplement: Vitamin D3

Arm 2: 4,000 IU vitamin D

EXPERIMENTAL

Subject will receive 4,000 IUs of vitamin D3/day for 24 weeks

Dietary Supplement: Vitamin D3

Arm 3: 10,000 IU vitamin D

EXPERIMENTAL

Subjet will receive 10,000 IUs of vitamin D3/day for 24 weeks

Dietary Supplement: Vitamin D3

Arm 4: Mixed vitamin D dosages

EXPERIMENTAL

Subject will receive 600 IUs of vitamin D3/day for the first 8 weeks, 4,000 IUs of vitamin D3/day for the next 8 weeks, and 10,000 IUs of vitamin D3/day for the final 8 weeks.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D provided in capsule form

Arm 1: 600 IU vitamin D; Arm 2: 4,000 IU vitamin D; Arm 3: 10,000 IU vitamin D; Arm 4: Mixed vitamin D dosages

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female adults
• Age 18-50 years
• BMI \<30
• hydroxyvitamin D \< 29 ng/mL
• No medications or disorders that would affect vitamin D metabolism
• Women must be on birth control and not pregnant based on a negative pregnancy test at baseline
• Ability and willingness to give informed consent and comply with protocol requirements

You may not qualify if:

• Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogues
• Pregnancy
• History of elevated serum calcium (\>10.6 mg%); that is corrected for albumin concentration
• Chronic hepatic or renal failure
• Supplementation with over the counter formulations of vitamin D2 or vitamin D3
• Subjects with a history of an adverse reaction to orally administered vitamin D.
• Subjects who are taking oral Dilantin or glucocorticoids.
• History of intestinal malabsorption (i.e. cystic fibrosis, fat malabsorption syndrome, Crohn's Disease, gastric bypass surgery).
• Inability to give informed consent
• Vacation plans to warmer climates (Florida, Southern CA, tropics) during study participation

Sponsors & Collaborators

• Boston University: lead
• Pure North S'Energy Foundation: collaborator

Study Sites (1)

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael Holick, MD,PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 5, 2016
• Study Start: December 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 6, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)