Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives

NCT02757872 | Completed Phase 3 Results DMC

• 2 other identifiers: 2014-3778R01DK102952
• Study Type: interventional
• Target: 2,232
• Locations: 1 country
• Sites: 1

Brief Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT01169259) is an ongoing randomized clinical trial in 25,875 US men and women investigating whether taking dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor (R) fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The VITAL Kidney Function in Hypertension ancillary study will evaluate the effects of vitamin D or omega-3 fatty acids on kidney function among participants with baseline hypertension.

Conditions

Hypertension; Kidney Diseases

Keywords

Hypertension; Kidney Diseases; Vitamin D; Omega 3 fatty acids

Outcome Measures

Primary Outcomes (1)

• Change in Estimated Glomerular Filtration Rate

  Serum creatinine and cystatin C measurement pre-randomization and year 4

  Baseline and 4 years

Secondary Outcomes (1)

• Confirmation of Microalbuminuria

  4 years post-randomization

Study Arms (4)

Vitamin D and Omega-3 Fatty acids

ACTIVE COMPARATOR

Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Dietary Supplement: Vitamin D3; Drug: Omega-3 Fatty acids

Vitamin D and Omega-3 Fatty acid Placebo

ACTIVE COMPARATOR

Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)

Dietary Supplement: Vitamin D3; Dietary Supplement: Fish oil placebo

Vitamin D Placebo and Omega-3 Fatty acids

ACTIVE COMPARATOR

Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]). Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo

Drug: Omega-3 Fatty acids; Dietary Supplement: Vitamin D3 placebo

Vitamin D Placebo and Omega-3 Fatty acid Placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day

Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day

Vitamin D and Omega-3 Fatty acid Placebo; Vitamin D and Omega-3 Fatty acids

Omega-3 Fatty acids DRUG

Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])

Also known as: Fish oil

Vitamin D Placebo and Omega-3 Fatty acids; Vitamin D and Omega-3 Fatty acids

Vitamin D3 placebo DIETARY_SUPPLEMENT

Vitamin D3 placebo

Vitamin D Placebo and Omega-3 Fatty acid Placebo; Vitamin D Placebo and Omega-3 Fatty acids

Fish oil placebo DIETARY_SUPPLEMENT

Fish oil placebo

Vitamin D Placebo and Omega-3 Fatty acid Placebo; Vitamin D and Omega-3 Fatty acid Placebo

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in VITAL (NCT01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study

You may not qualify if:

• Diagnosis of diabetes mellitus

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Brigham and Women's Hospital: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hypertension; Kidney Diseases

Interventions

Cholecalciferol; Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Oils

Results Point of Contact

• Title: Dr. Michal Melamed
• Organization: NYU Langone

michal.melamed@nyulangone.org

212-263-0705

Study Officials

• Michal L Melamed, MD, MHS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parent (VITAL; NCT01169259) study was based upon a 2x2 factorial design

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2016
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2024-05

Locations

US (1)