Trial | NCT03310307  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Vit D ...

  • Study Participants

    100
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.
Study Started
Apr 01
2016
Primary Completion
Aug 30
2016
Study Completion
Oct 30
2016
Last Update
Oct 16
2017

Drug Vit D

50,000 IU

  • Other names: Biodal

Other Placebo

vitamin D3 Active Comparator

50,000 IU

Placebo Placebo Comparator

Similar in size, shape and color to vitamin D3

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
No Results Posted