Effect of Vitamin D3 and Omega-3FA on Estradiol

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Omega3-FA; Dietary Supplement: VD3 and Omega-3FA; Dietary Supplement: VD3; Other: Control

• Registration Number: NCT03333564
• Lead Sponsor: Applied Science Private University

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.

Study Timeline

• Study Start: 2016-11
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-10
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-11-03
• Last Update Submitted: 2017-11-03
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omega3-FA group	Omega3-FA	1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
VD3 and Omega-3FA group	VD3 and Omega-3FA	50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3FA) once daily
VD3 group	VD3	treated with 50,000 IU VD3 / week
Control group	Control	No intervention was given

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of 25-hydroxyvitamin D, estradiol	8 weeks	Concentration

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of PTH, Ca	8 weeks	Concentration