Effect of Vitamin D3 and Omega-3FA on Estradiol

Vitamin D Deficiency Clinical Trial

Official title:

Effect of Vitamin D3 and Omega-3FA on Estradiol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333564
• Other study ID #: DRGS-2014-2015-165
• Status: Completed
• Phase: N/A
• First received: October 27, 2017
• Last updated: November 3, 2017
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• VD3
50,000 IU VD3 / week for 8 weeks
• Omega3-FA
300 mg of omega3-FA once daily for 8 weeks
• VD3 and Omega-3FA
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks

Other:
• Control
No intervention was given

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

References & Publications (1)

Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of 25-hydroxyvitamin D, estradiol	Concentration	8 weeks
Secondary	Plasma concentrations of PTH, Ca	Concentration	8 weeks