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Effect of Vitamin D3 and Omega-3FA on Estradiol

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VD3
Omega3-FA
VD3 and Omega-3FA
Control
Sponsored by
Applied Science Private University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D3, Vitamin D deficiency, estradiol, omega-3 fatty acids, menopausal

Eligibility Criteria

22 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Other

    Arm Label

    VD3 group

    omega3-FA group

    VD3 and Omega-3FA group

    Control group

    Arm Description

    treated with 50,000 IU VD3 / week

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

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

    No intervention was given

    Outcomes

    Primary Outcome Measures

    Plasma concentrations of 25-hydroxyvitamin D, estradiol
    Concentration

    Secondary Outcome Measures

    Plasma concentrations of PTH, Ca
    Concentration

    Full Information

    First Posted
    October 27, 2017
    Last Updated
    November 3, 2017
    Sponsor
    Applied Science Private University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03333564
    Brief Title
    Effect of Vitamin D3 and Omega-3FA on Estradiol
    Official Title
    Effect of Vitamin D3 and Omega-3FA on Estradiol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Applied Science Private University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency
    Keywords
    Vitamin D3, Vitamin D deficiency, estradiol, omega-3 fatty acids, menopausal

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    116 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VD3 group
    Arm Type
    Experimental
    Arm Description
    treated with 50,000 IU VD3 / week
    Arm Title
    omega3-FA group
    Arm Type
    Experimental
    Arm Description
    1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
    Arm Title
    VD3 and Omega-3FA group
    Arm Type
    Experimental
    Arm Description
    50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3FA) once daily
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    No intervention was given
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    VD3
    Intervention Description
    50,000 IU VD3 / week for 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega3-FA
    Intervention Description
    300 mg of omega3-FA once daily for 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    VD3 and Omega-3FA
    Intervention Description
    50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    No intervention was given
    Primary Outcome Measure Information:
    Title
    Plasma concentrations of 25-hydroxyvitamin D, estradiol
    Description
    Concentration
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Plasma concentrations of PTH, Ca
    Description
    Concentration
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Premenopausal females
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mahmoud S Abu-Samak, PhD
    Organizational Affiliation
    Applied Science Private University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    all IPD that underlie results in a publication
    IPD Sharing Time Frame
    when summary data are published
    IPD Sharing Access Criteria
    open access
    Citations:
    PubMed Identifier
    18400738
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30787641
    Citation
    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.
    Results Reference
    derived

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    Effect of Vitamin D3 and Omega-3FA on Estradiol

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