The Effect of Vitamin D Supplementation on HIV-associated Platelet Hyperreactivity

NCT02217553 | Completed DMC

• 1 other identifier: 1402001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Platelets play pivotal role in atherosclerosis and acute cardiovascular events. Platelet hyperreactivity and increase platelet-monocyte aggregate (PMA) formation are found in HIV infected patients, which may contribute to the excess cardiovascular risk. Low level of vitamin D has been associated with the presence of cardiovascular diseases. The aim of our study is to determine the effect of vitamin D supplementation on platelet activation, platelet reactivity and platelet-leukocyte complex formation in asymptomatic HIV-infected patients treated with ART

Conditions

Blood Platelet Disorders; Vitamin D Deficiency

Keywords

platelet; P-selectin; platelet-fibrinogen binding; platelet-monocye aggregate formation; vitamin D

Outcome Measures

Primary Outcomes (1)

• The effect of vitamin D supplementation on HIV-associated platelet hyperreactivity

  Mean Fluorescence Intensity of the platelet reactivity curve before and after receiving vitamin D

  Three months

Secondary Outcomes (1)

• The effect of vitamin D supplementation in platelet-monocyte aggregate formation

  three months

Study Arms (1)

vitamin D (cholecalciferol)

EXPERIMENTAL

All study participants will receive vitamin D supplementation (soft gel capsule containing cholecalciferol 400 IU) to be consumed 2 soft gel capsules daily for three consecutive months. The effect on the platelet parameters specified above will be determined before start cholecalciferol supplementation and after three months.

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

The study participants will receive 180 soft gel cholecalciferol capsules, to be taken 2 capsules once a day for 90 days

Also known as: Teorol

vitamin D (cholecalciferol)

Eligibility Criteria

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

You may qualify if:

• \>18 years
• Treated with suppressive first-line ART for at least 12 months
• Compliant to ART and procedures of Teratai clinic
• No signs or symptoms

You may not qualify if:

• Use of aspirin or other platelet function inhibitors.
• Any sign or symptom
• Known active opportunistic infection
• Active illicit drug users or any other comorbidity
• History of failing ART or non-compliance.
• Pregnancy

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Klinik Teratai Hasan Sadikin General

Bandung, West Java, 40161, Indonesia

Location

Related Links

• Official web site of Faculty of Medicine, Universitas Padjadjaran
• Official web site of Radboud University Medical Center

MeSH Terms

Conditions

Blood Platelet Disorders; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Andre van der Ven, Professor

  Radboud University Medical Center

  STUDY CHAIR

• Quirijn de Mast, Doctor

  Radboud University Medical Center

  STUDY DIRECTOR

• Rudi Wisaksana, Doctor

  Universitas Padjadjaran

  STUDY DIRECTOR

• Agnes R Indrati, Doctor

  Universitas Padjadjaran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

ID (1)