Effect of Vitamin D3 Supplementation on Cardiometabolic Risk

NCT02359214 | Completed

• 1 other identifier: 855/13/AT/CSN
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Supplementation studies with vitamin D have been performed where cardiometabolic risk markers have been assessed but these are few, and results are inconsistent. Hence, the purpose of this study is to determine:

1. 1.Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese adult participants for 8 weeks will significantly increase circulating concentrations of 25(OH)D or achieve optimal vitamin D status.
2. 2.Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese participants for 8 weeks will significantly improve the cardiometabolic parameters measured.
3. 3.To evaluate the relationship between these variables and 25(OH)D concentration. We hypothesise that there will be a significant increase in plasma 25(OH)D following 8 weeks (56days) supplementation of oral vitamin D3 at a dose of 5000IU/day (125µg); Administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese participants for 8 weeks will significantly improve the cardio metabolic parameters measured, and there will be a relationship between these variables and 25(OH)D concentrations.

Conditions

Cardiovascular Disease; Diabetes; Bone Disease

Keywords

Vitamin D; Cardiovascular disease; Diabetes; Obesity; Cardiometabolic; Bone disease

Outcome Measures

Primary Outcomes (1)

• Pulsewave Velocity

  Arterial Stiffness

  0,4 and 8 weeks

Secondary Outcomes (5)

• Aix Brachial

  0,4 and 8 weeks

• Aix Aortic

  0,4 and 8 weeks

• Mean Arterial Pressure

  0,4 and 8 weeks

• Pulse Pressure

  0,4 and 8 weeks

• Systolic Blood Pressure

  0,4 and 8 weeks

Other Outcomes (17)

• Diastolic Blood Pressure

  0,4 and 8 weeks

• E-selectin

  0,4 and 8 weeks

• LDL Cholesterol

  0,4 and 8 weeks

Study Arms (2)

Vitamin D3 Supplement

ACTIVE COMPARATOR

This group will receive a daily dose of 5000IU (125µg) vitamin D3 (which is half of the recommended safe tolerable upper intake level of vitamin D for healthy individuals) for eight weeks.

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

This group will receive 100% lactose placebo daily for eight weeks.

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

5000IU (125mcg) vitamin D3 tablet daily over 8 weeks (56 days).

Also known as: Cholecalciferol

Vitamin D3 Supplement

Placebo OTHER

100% Lactose tablet daily over 8 weeks (56 days).

Also known as: Non-active ingredient

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy males aged 18-65 years,
• Those with a BMI ≥ 25kg/m2
• Those with plasma 25(OH)D concentrations \< 75nmol/l

You may not qualify if:

• Those with gastrointestinal disease, cardiovascular disease, diabetes, osteoporosis, renal and hepatic disorders
• Those taking weight loss drugs
• Those taking cholesterol lowering drugs
• Those currently on a weight reduction programme
• Those with blood pressure ≥ 160/90 mm Hg
• Those taking vitamin D/calcium supplements

Sponsors & Collaborators

• University of Chester: lead

Study Sites (1)

University of Chester

Chester, CH1 4BJ, United Kingdom

Location

Related Publications (1)

• Agbalalah T, Mushtaq S. Effect of vitamin D3 supplementation on cardiometabolic disease risk among overweight/obese adult males in the UK: A pilot randomised controlled trial. J Hum Nutr Diet. 2023 Feb;36(1):216-225. doi: 10.1111/jhn.13021. Epub 2022 May 9.

  PMID: 35451536 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Bone Diseases; Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sohail Mushtaq, PhD

  University of Chester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)