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Effect of Vitamin D3 and Omega-3FA on Estradiol

NCT ID: NCT03333564

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Vitamin D Deficiency

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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VD3 group

treated with 50,000 IU VD3 / week

Group Type EXPERIMENTAL

VD3

Intervention Type DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks

omega3-FA group

1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily

Group Type EXPERIMENTAL

Omega3-FA

Intervention Type DIETARY_SUPPLEMENT

300 mg of omega3-FA once daily for 8 weeks

VD3 and Omega-3FA group

50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3FA) once daily

Group Type EXPERIMENTAL

VD3 and Omega-3FA

Intervention Type DIETARY_SUPPLEMENT

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

Control group

No intervention was given

Group Type OTHER

Control

Intervention Type OTHER

No intervention was given

Interventions

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VD3

50,000 IU VD3 / week for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Omega3-FA

300 mg of omega3-FA once daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

VD3 and Omega-3FA

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

Intervention Type DIETARY_SUPPLEMENT

Control

No intervention was given

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Applied Science Private University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud S Abu-Samak, PhD

Role: PRINCIPAL_INVESTIGATOR

Applied Science Private University

References

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Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.

Reference Type BACKGROUND
PMID: 18400738 (View on PubMed)

Al-Shaer AH, Abu-Samak MS, Hasoun LZ, Mohammad BA, Basheti IA. Assessing the effect of omega-3 fatty acid combined with vitamin D3 versus vitamin D3 alone on estradiol levels: a randomized, placebo-controlled trial in females with vitamin D deficiency. Clin Pharmacol. 2019 Feb 4;11:25-37. doi: 10.2147/CPAA.S182927. eCollection 2019.

Reference Type DERIVED
PMID: 30787641 (View on PubMed)

Other Identifiers

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DRGS-2014-2015-165

Identifier Type: -

Identifier Source: org_study_id