NCT03333564

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

November 7, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

October 27, 2017

Last Update Submit

November 3, 2017

Conditions

Vitamin D Deficiency

Keywords

Vitamin D3Vitamin D deficiencyestradiolomega-3 fatty acidsmenopausal

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of 25-hydroxyvitamin D, estradiol

    Concentration

    8 weeks

Secondary Outcomes (1)

  • Plasma concentrations of PTH, Ca

    8 weeks

Study Arms (4)

VD3 group

EXPERIMENTAL

treated with 50,000 IU VD3 / week

Dietary Supplement: VD3

omega3-FA group

EXPERIMENTAL

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

Dietary Supplement: Omega3-FA

VD3 and Omega-3FA group

EXPERIMENTAL

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

Dietary Supplement: VD3 and Omega-3FA

Control group

OTHER

No intervention was given

Other: Control

Interventions

VD3DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks

VD3 group
Omega3-FADIETARY_SUPPLEMENT

300 mg of omega3-FA once daily for 8 weeks

omega3-FA group
VD3 and Omega-3FADIETARY_SUPPLEMENT

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

VD3 and Omega-3FA group
ControlOTHER

No intervention was given

Control group

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenopausal females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal females
  • Medical diagnosis of vitamin D deficiency (VD \< 30 ng / ml)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 18400738BACKGROUND

  • 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.

    PMID: 30787641DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Mahmoud S Abu-Samak, PhD

    Applied Science Private University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 7, 2017

Study Start

November 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

November 7, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
when summary data are published
Access Criteria
open access