Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

Al-Balqa Applied University

Status and phase: Completed; Phase 2

Conditions: Vitamin D Deficiency; Homocystinaemia

Treatments: Drug: Vit D; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03310307

Hcy-VitD-01

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups, including a placebo group

vitamin D3

Active Comparator group

Description:

50,000 IU

Treatment:

Drug: Vit D

Placebo

Placebo Comparator group

Description:

Similar in size, shape and color to vitamin D3

Treatment:

Other: Placebo