Effect of Vitamin D3 and Omega-3FA on Estradiol

Applied Science Private University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: VD3; Other: Control; Dietary Supplement: Omega3-FA; Dietary Supplement: VD3 and Omega-3FA

Study type: Interventional

Funder types: Other

Identifiers

NCT03333564

DRGS-2014-2015-165

Details and patient eligibility

About

The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels.

Full description

The data about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum levels of estradiol (E2) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the E2 levels.

This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum E2 levels in premenopausal females with vitamin D deficiency (VDD).

This randomized, placebo-controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on the mid-follicular serum levels of E2 and 25-hydroxy vitamin D (25OHD). This study was conducted during winter in 86 healthy premenopausal Jordanian females with VDD with a mean age of (32.8 ± 8.9) years. Fasting serum levels for 25OHD, E2, PTH (parathyroid hormon), calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial.

Enrollment: 116 patients

Sex: Female

Ages: 22 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Premenopausal females
• Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml)

Exclusion criteria

• Women previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation. Women who are pregnant, breastfeeding or using hormonal contraceptives were also excluded.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 4 patient groups

VD3 group

Experimental group

Description:

treated with 50,000 IU VD3 / week

Treatment:

Dietary Supplement: VD3

omega3-FA group

Experimental group

Description:

1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily

Treatment:

Dietary Supplement: Omega3-FA

VD3 and Omega-3FA group

Experimental group

Description:

50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3FA) once daily

Treatment:

Dietary Supplement: VD3 and Omega-3FA

Control group

Other group

Description:

No intervention was given

Treatment:

Other: Control