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Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

NCT ID: NCT03310307

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2016-10-30

Brief Summary

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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

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Conditions

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Homocystinaemia Vitamin D Deficiency

Keywords

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Homocysteine Overweight vitamin D3 Reproductive women RCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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vitamin D3

50,000 IU

Group Type ACTIVE_COMPARATOR

Vit D

Intervention Type DRUG

50,000 IU

Placebo

Similar in size, shape and color to vitamin D3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Vit D

50,000 IU

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Biodal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role collaborator

Al-Balqa Applied University

OTHER

Sponsor Role lead

Responsible Party

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Nahla Bayyari

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jehan M Hamadneh, FRCOG

Role: PRINCIPAL_INVESTIGATOR

JUST

Nahla S Al-Bayyari, PhD

Role: STUDY_CHAIR

BAU

Locations

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King Abdullah University Hospital

Irbid, , Jordan

Site Status

Countries

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Jordan

References

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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.

Reference Type DERIVED
PMID: 30442234 (View on PubMed)

Other Identifiers

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Hcy-VitD-01

Identifier Type: -

Identifier Source: org_study_id