Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310307
• Other study ID #: Hcy-VitD-01
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2017
• Last updated: October 13, 2017
• Start date: April 1, 2016
• Est. completion date: October 30, 2016

Study information

• Verified date: October 2017
• Source: Al-Balqa Applied University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Homocystinaemia
• Overweight
• Vitamin D Deficiency

Intervention

Drug:
• Vit D
50,000 IU

Other:
• Placebo

Locations

Country	Name	City	State
Jordan	King Abdullah University Hospital	Irbid

Sponsors (2)

Lead Sponsor	Collaborator
Al-Balqa Applied University	Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH)D3	vitamin D in serum	2 months
Secondary	Homocysteine	serum total homocysteine	2 months