Effect of Vitamin D3 and Omega-3FA on Estradiol

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03333564

Enrollment

116

Registered

2017-11-07

Start date

2016-11-30

Completion date

2017-02-28

Last updated

2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D3, Vitamin D deficiency, estradiol, omega-3 fatty acids, menopausal

Brief summary

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

Detailed 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.

Interventions

DIETARY_SUPPLEMENTVD3

50,000 IU VD3 / week for 8 weeks

DIETARY_SUPPLEMENTOmega3-FA

300 mg of omega3-FA once daily for 8 weeks

DIETARY_SUPPLEMENTVD3 and Omega-3FA

50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks

OTHERControl

No intervention was given

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

22 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentrations of 25-hydroxyvitamin D, estradiol	8 weeks	Concentration

Secondary

Measure	Time frame	Description
Plasma concentrations of PTH, Ca	8 weeks	Concentration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026