Effect of Vitamin D3 and Omega-3FA on Estradiol

A

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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