Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

Phase 2

Completed

• Conditions: Homocystinaemia; Vitamin D Deficiency
• Interventions: Drug: Vit D; Other: Placebo

• Registration Number: NCT03310307
• Lead Sponsor: Al-Balqa Applied University

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 available

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2016-08-30
• Study Completion: 2016-10-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-13
• Last Update Submitted: 2017-10-13
• Study First Posted: 2017-10-16
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D3	Vit D	50,000 IU
Placebo	Placebo	Similar in size, shape and color to vitamin D3

Primary Outcome Measures

Name	Time	Method
25(OH)D3	2 months	vitamin D in serum

Secondary Outcome Measures

Name	Time	Method
Homocysteine	2 months	serum total homocysteine

Trial Locations

Locations (1)

King Abdullah University Hospital; 🇯🇴 Irbid, Jordan