Back to resultsVitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women
Primary Purpose
Homocystinaemia, Vitamin D Deficiency
Status
Completed
Phase
Phase 2
Locations
Jordan
Study Type
Interventional
Intervention
Vit D
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Homocystinaemia focused on measuring Homocysteine, Overweight, vitamin D3, Reproductive women, RCT
Eligibility Criteria
Inclusion Criteria:
- Overweight (BMI between 25-29.99 kg/m2)
- Had 25(OH)D < 20 ng/mL
- Had normal vitamin B-12 and folic acid levels
- Not diagnosed with any chronic diseases
- Agreed to participat in the study
Exclusion Criteria:
- age < 18 or > 49 years
- BMI > 30 kg/m2 or < 25 kg/m2
- 25 (OH)D level > 20 ng/ml
- tHcy levels greater than 100 µmol/L
- Abnormal vitamin B-12 or folic acid levels
- Chronic diseases
- Pregnant or lactating
Sites / Locations
- King Abdullah University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
vitamin D3
Placebo
Arm Description
50,000 IU
Similar in size, shape and color to vitamin D3
Outcomes
Primary Outcome Measures
25(OH)D3
vitamin D in serum
Secondary Outcome Measures
Homocysteine
serum total homocysteine
Full Information
NCT ID
NCT03310307
First Posted
October 11, 2017
Last Updated
October 13, 2017
Sponsor
Al-Balqa Applied University
Collaborators
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03310307
Brief Title
Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women
Official Title
Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
October 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Balqa Applied University
Collaborators
Jordan University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo and vitamin D group over time showed significant difference on 30 and 60 days of intervention. Mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin D group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Homocystinaemia, Vitamin D Deficiency
Keywords
Homocysteine, Overweight, vitamin D3, Reproductive women, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking Description
Double blind
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D3
Arm Type
Active Comparator
Arm Description
50,000 IU
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Similar in size, shape and color to vitamin D3
Intervention Type
Drug
Intervention Name(s)
Vit D
Other Intervention Name(s)
Biodal
Intervention Description
50,000 IU
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
25(OH)D3
Description
vitamin D in serum
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Homocysteine
Description
serum total homocysteine
Time Frame
2 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Attending obstetric and gynecology clinics at King Abdullah University Hospital
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight (BMI between 25-29.99 kg/m2)
Had 25(OH)D < 20 ng/mL
Had normal vitamin B-12 and folic acid levels
Not diagnosed with any chronic diseases
Agreed to participat in the study
Exclusion Criteria:
age < 18 or > 49 years
BMI > 30 kg/m2 or < 25 kg/m2
25 (OH)D level > 20 ng/ml
tHcy levels greater than 100 µmol/L
Abnormal vitamin B-12 or folic acid levels
Chronic diseases
Pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jehan M Hamadneh, FRCOG
Organizational Affiliation
JUST
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nahla S Al-Bayyari, PhD
Organizational Affiliation
BAU
Official's Role
Study Chair
Facility Information:
Facility Name
King Abdullah University Hospital
City
Irbid
Country
Jordan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30442234
Citation
Al-Bayyari N, Al-Zeidaneen S, Hailat R, Hamadneh J. Vitamin D3 prevents cardiovascular diseases by lowering serum total homocysteine concentrations in overweight reproductive women: A randomized, placebo-controlled clinical trial. Nutr Res. 2018 Nov;59:65-71. doi: 10.1016/j.nutres.2018.07.012. Epub 2018 Jul 29.
Results Reference
derived
Learn more about this trial
Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women
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