Vitamin D DeficiencyNCT03333564
Effect of Vitamin D3 and Omega-3FA on Estradiol
A study testing VD3, Omega3-FA and VD3 and Omega-3FA in people with Vitamin D Deficiency, run by Applied Science Private University.
Trial summary
The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- VD3, Omega3-FA and VD3 and Omega-3FA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal females
- Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml)
Who cannot join
- 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.
About this study
The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- VD3, Omega3-FA, VD3 and Omega-3FA, Control
- Keywords
- Vitamin D3, Vitamin D deficiency, estradiol, omega-3 fatty acids, menopausal
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VD3Dietary supplement
50,000 IU VD3 / week for 8 weeks
Omega3-FADietary supplement
300 mg of omega3-FA once daily for 8 weeks
VD3 and Omega-3FADietary supplement
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
ControlOther
No intervention was given
| Study group | Role | What they receive |
|---|---|---|
| VD3 group | Experimental | treated with 50,000 IU VD3 / week Receives: Dietary Supplement: VD3 |
| omega3-FA group | Experimental | 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily Receives: 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 Receives: Dietary Supplement: VD3 and Omega-3FA |
| Control group | Other | No intervention was given Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of 25-hydroxyvitamin D, estradiol
Concentration
Measured: 8 weeks
Secondary outcomes (1)
Plasma concentrations of PTH, Ca
Concentration
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud S Abu-Samak, PhD, Principal investigator, Applied Science Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333564
- Sponsor's protocol ID
- DRGS-2014-2015-165
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 18400738Al-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.
PubMed 30787641
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 and Omega-3FA on Estradiol
- ClinicalTrials.gov ID
- NCT03333564
- Acronym / sponsor ID
- DRGS-2014-2015-165
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D3, Vitamin D deficiency, estradiol, omega-3 fatty acids, menopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VD3 group | Experimental | Dietary Supplement: VD3treated with 50,000 IU VD3 / week |
| omega3-FA group | Experimental | Dietary Supplement: Omega3-FA1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily |
| VD3 and Omega-3FA group | Experimental | Dietary Supplement: VD3 and Omega-3FA50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3FA) once daily |
| Control group | Other | Other: ControlNo intervention was given |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Premenopausal females
- Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VD350,000 IU VD3 / week for 8 weeks | Dietary supplement | VD3 group |
| Omega3-FA300 mg of omega3-FA once daily for 8 weeks | Dietary supplement | omega3-FA group |
| VD3 and Omega-3FA50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks | Dietary supplement | VD3 and Omega-3FA group |
| ControlNo intervention was given | Other | Control group |
Primary outcome
Plasma concentrations of 25-hydroxyvitamin D, estradiol
Time frame: 8 weeks
Concentration
1 secondary outcome
Plasma concentrations of PTH, Ca
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 18400738Holick 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.
- Derived from this study: PubMed 30787641Al-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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud S Abu-Samak, PhD principal investigator
Applied Science Private University
Questions about this trial
What is this clinical trial studying?
A study testing VD3, Omega3-FA and VD3 and Omega-3FA in people with Vitamin D Deficiency, run by Applied Science Private University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of 25-hydroxyvitamin D, estradiol (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03333564, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.