Vitamin D3 + K2 for Vitamin Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how vitamin D3 and K2 supplements affect blood levels and the gut microbiome, the community of bacteria in the digestive system. Participants will take either one of the vitamins, a combination of both, or a placebo daily for 90 days. The goal is to determine how these vitamins, along with diet and lifestyle, influence gut health and vitamin absorption. Individuals with a vitamin D level of 30 ng/mL or lower, who are willing to stop their current vitamin supplements, might be suitable candidates. The study involves completing questionnaires, taking body measurements, and providing blood and stool samples. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of vitamin impacts on gut health.
Do I have to stop taking my current medications for the trial?
You will need to stop taking any vitamin D3 and K2 supplements for 4.5 months. If you are currently using antibiotics, anticoagulants, or weight loss medications, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that vitamin D3 and vitamin K2 are generally safe for people. Vitamin D3 is usually well-tolerated in normal amounts, but large doses over time can cause issues such as an upset stomach, muscle weakness, and more serious problems like kidney stones.
Vitamin K2 is also considered safe, with no major side effects reported when taken in typical amounts. Some individuals might experience an upset stomach, but serious side effects are rare. Taking vitamin D3 and K2 together is safe when used as directed, with no significant safety concerns reported.
Overall, these vitamins are usually well-tolerated, but following dosage instructions is important to avoid potential side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they explore the potential benefits of combining Vitamin D3 and K2, which isn't a common approach in current standard treatments for vitamin deficiency. Most treatments focus solely on replenishing Vitamin D levels. However, this combination aims to enhance the body's use of calcium, potentially improving bone and heart health by ensuring calcium is directed to the right places. Additionally, these vitamins are administered in a straightforward oral supplement, making them easy to incorporate into daily routines.
What evidence suggests that this trial's treatments could be effective for vitamin deficiency?
This trial will compare the effects of different vitamin supplementation regimens. Research has shown that vitamin D3, which participants may receive, is crucial for maintaining healthy bones and can prevent issues like soft or brittle bones. Studies suggest that vitamin K2, another treatment option, supports bone health by aiding the body's use of calcium, essential for strong bones. Taking vitamin D3 and K2 together, as tested in one of the trial arms, might enhance bone strength more effectively than taking either alone, particularly for postmenopausal women. Additionally, these vitamins together may benefit heart health and help lower blood sugar levels. Overall, early research suggests that combining vitamins D3 and K2 could offer several health benefits.678910
Who Is on the Research Team?
Mary S McCarthy, PhD
Principal Investigator
Madigan AMC
Are You a Good Fit for This Trial?
This trial is for healthcare workers who might not have enough vitamin D or K. They should be willing to take supplements or a placebo and provide blood and stool samples. Participants will also need to fill out questionnaires and get their body composition and blood pressure checked.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take vitamin D3, vitamin K2, a combination of both, or a placebo daily for 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vitamin D3 and K2 Supplementation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Madigan Army Medical Center
Lead Sponsor