Your session is about to expire
← Back to Search
Vitamin Supplement
Vitamin D for Vitamin D Deficiency
Phase 1 & 2
Waitlist Available
Led By Anne Marie Z Jukic, Ph.D.
Research Sponsored by National Institute of Environmental Health Sciences (NIEHS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having natural, spontaneous menstrual cycles (no hormonal therapy) less than 50 days in length.
Having natural, spontaneous menstrual cycles (no hormonal therapy) less than 50 days in length
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study Summary
This trial is looking at the effect of vitamin D supplementation on hormones during a menstrual cycle in order to see if it plays a role in menstrual cycle health.
Who is the study for?
Women aged 19-40 with regular menstrual cycles not on hormonal therapy or contraceptives, who are vitamin D deficient and willing to take a weekly vitamin D capsule. They must be non-pregnant, not trying to conceive, and able to participate for about 4 months.Check my eligibility
What is being tested?
The trial is testing the impact of different doses of vitamin D supplements on menstrual cycle hormones in women with vitamin D deficiency compared to a placebo in those sufficient in vitamin D. It involves physical exams, blood samples, swabs, diaries, ovulation tests, urine collection at home and an online survey.See study design
What are the potential side effects?
Vitamin D supplementation is generally safe but can sometimes cause side effects such as nausea, fatigue, mood changes or elevated calcium levels which could lead to kidney stones or other issues if taken excessively.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My menstrual cycles are natural and shorter than 50 days.
Select...
My menstrual cycles are natural and shorter than 50 days.
Select...
I am between 19 and 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To examine the effect of vitamin D supplementation on hypothalamic-pituitary-ovarian axis hormones.
Secondary outcome measures
Determine the impact of Vitamin D supplementation in reproductive-aged women by assaying the metabolome before and after vitamin D supplementation.
To examine the change in whole blood metals levels in response to vitamin D supplementation.
To investigate the effect of vitamin D supplementation on endometrial stromal cell function.
+2 moreSide effects data
From 2016 Phase 4 trial • 1366 Patients • NCT0170911012%
Back pain
7%
Arthralgia
3%
Fall
1%
Hip fracture
1%
Humerus fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1/High Dose Vitamin DExperimental Treatment1 Intervention
Deficient women will be assigned to the Endocrine Society recommendation for deficiency, 50,000 IU/week.
Group II: 2/PlaceboPlacebo Group1 Intervention
Sufficient women who will receive placebo instead of Vitamin D supplementation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
2013
Completed Phase 4
~3470
Find a Location
Who is running the clinical trial?
National Institute of Environmental Health Sciences (NIEHS)Lead Sponsor
284 Previous Clinical Trials
1,232,680 Total Patients Enrolled
Anne Marie Z Jukic, Ph.D.Principal InvestigatorNational Institute of Environmental Health Sciences (NIEHS)
2 Previous Clinical Trials
404 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures.I take calcium supplements and cannot stop during the study.I am not willing to stop taking my vitamin D supplements not provided by the study.I have been diagnosed with polycystic ovarian syndrome.My menstrual cycles are natural and shorter than 50 days.I am currently using hormones, including birth control.I am currently using a hormonal IUD.I have celiac disease.I am either younger than 19 or older than 40 years old.I do not have conditions like high calcium, tuberculosis, bone cancer, sarcoidosis, Williams syndrome, or serious kidney disease.I have been diagnosed with liver disease.I have had cancer other than skin cancer.I have a known heart condition.I have used hormone therapy in the last 60 days.I have diabetes.I have had gastric bypass surgery.I can read and speak English well enough to understand medical forms and instructions.My menstrual cycles are natural and shorter than 50 days.I can take a vitamin D capsule weekly and will stick to the schedule.I am between 19 and 40 years old.If you are sexually active, you need to use a birth control method that does not involve hormones.I have Crohn's Disease.I have been taking vitamin D supplements regularly for over a month.
Research Study Groups:
This trial has the following groups:- Group 1: 2/Placebo
- Group 2: 1/High Dose Vitamin D
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
National Institute of Environmental Health Sciences (NIEHS)
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger