Vitamin D3 Treatment and Homocysteine Concentrations Amon... | NCT03310307

Studies
Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

NCT03310307

Sponsor

Al-Balqa Applied University

Status

Completed

Last Update Posted

Oct 16, 2017Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Homocystinaemia
Vitamin D Deficiency

Interventions

Vit D
Placebo

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Aug 30, 2016Actual

Completion Date

Oct 30, 2016Actual

First Submitted Date

Oct 11, 2017

First Submission Date that Met QC Criteria

Oct 13, 2017

First Posted Date

Oct 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2017

Last Update Posted Date

Oct 16, 2017Actual

Name	Class
Jordan University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin D3	Active Comparator	50,000 IU	Drug: Vit D
Placebo	Placebo Comparator	Similar in size, shape and color to vitamin D3	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vit D	Drug	50,000 IU	vitamin D3	Biodal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
25(OH)D3	vitamin D in serum	2 months

Secondary Outcomes

Measure	Description	Time Frame
Homocysteine	serum total homocysteine	2 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Attending obstetric and gynecology clinics at King Abdullah University Hospital

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jehan M Hamadneh, FRCOG	JUST	Principal Investigator
Nahla S Al-Bayyari, PhD	BAU	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Abdullah University Hospital		Irbid			Jordan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30442234	Derived	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.

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

ID	Term
D014808	Vitamin D Deficiency
D050177	Overweight