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Completed

NCT Number: NCT03333564

Effect of Vitamin D3 and Omega-3FA on Estradiol

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

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Key information

Age range

22 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VD3

Dietary Supplement

50,000 IU VD3 / week for 8 weeks

Omega3-FA

Dietary Supplement

300 mg of omega3-FA once daily for 8 weeks

VD3 and Omega-3FA

Dietary Supplement

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

Control

Other

No intervention was given

Primary outcomes

  1. Plasma concentrations of 25-hydroxyvitamin D, estradiol

    Time frame: 8 weeks

    Concentration

Secondary outcomes

  1. Plasma concentrations of PTH, Ca

    Time frame: 8 weeks

    Concentration

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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