NCT03133975

Brief Summary

This study will be conducted to Assess possible reduction in lipid profile (LDL-Triglecerides-cholesterol) among pre-menopausal women in vit D group compared to standard treatment group after 3 months \& 6 month of follow up as prophylaxis step for atherosclerosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

April 26, 2017

Last Update Submit

August 17, 2018

Conditions

Dyslipidemias

Keywords

high dose vitamin Ddyslipidemiapremenopausal women

Outcome Measures

Primary Outcomes (1)

  • serum levels of LDL-HDL-Total cholesterol-triglecerides

    reduction in lipid profile significantly than controls

    3 months-6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Single high dose IM VIT D

Drug: Vitamin D3 (Treatment)

Control

ACTIVE COMPARATOR

Usual diet mix of carbohydrates - lipid - protein - minerals \& vitamins

Other: Mixed diet of carbohydrate and protein (Control)

Interventions

Vitamin D3 (Treatment)DRUG

Single high dose vitamin D3 in treatment of dyslipedemia

Also known as: divarol
Treatment
Mixed diet of carbohydrate and protein (Control)OTHER

Mixed diet of carbohydrate and protein

Control

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsto highlight the effect on females as it is more common among premenopausal women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal females (35-45 years)

You may not qualify if:

  • no co morbodity
  • no lipid lowering drugs or contraceptive pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Interventions

CholecalciferolTherapeuticsProteins

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsAmino Acids, Peptides, and Proteins

Study Officials

  • Nibal Murad, lectURER

    Mansoura University-Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala Abdel Malek, ass prof

CONTACT

01009172054halamalek@live.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial VITAMIN D for treatment of dyslipedemia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Industrial Medicine

Study Record Dates

First Submitted

April 26, 2017

First Posted

April 28, 2017

Study Start

April 1, 2017

Primary Completion

December 31, 2018

Study Completion

July 1, 2019

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)