Effect of Vitamin D3 and Omega-3FA on Estradiol

Study Overview
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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.

Official Title
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Effect of Vitamin D3 and Omega-3FA on Estradiol

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: VD3
* Dietary Supplement: Omega3-FA
* Dietary Supplement: VD3 and Omega-3FA
* Other: Control


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VD3 group<br>treated with 50,000 IU VD3 / week | Dietary Supplement: VD3<br>* 50,000 IU VD3 / week for 8 weeks<br>|
| Experimental: omega3-FA group<br>1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily | Dietary Supplement: Omega3-FA<br>* 300 mg of omega3-FA once daily for 8 weeks<br>|
| Experimental: VD3 and Omega-3FA group<br>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<br>* 50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks<br>|
| Other: Control group<br>No intervention was given | Other: Control<br>* No intervention was given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of 25-hydroxyvitamin D, estradiol | Concentration | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of PTH, Ca | Concentration | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D3, Vitamin D deficiency, estradiol, omega-3 fatty acids, menopausal