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
Trial Overview
The study tests the effects of vitamin D3, K2, both together, or a placebo on blood levels and gut bacteria in healthcare personnel. It involves taking one capsule daily for 90 days with follow-up visits over 4-6 months.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
Vitamin D3 125 mcg taken orally once daily for 90 days
Vitamin K2 180 mcg taken orally once daily for 90 days
Vitamin D3 125 mcg combined with vitamin K2 180 mcg taken orally once daily for 90 days
Inert capsule taken orally once daily for 90 days
Find a Clinic Near You
Who Is Running the Clinical Trial?
Madigan Army Medical Center
Lead Sponsor
Citations
Vitamin D - Health Professional Fact Sheet
In adults and adolescents, vitamin D deficiency can lead to osteomalacia, in which existing bone is incompletely or defectively mineralized ...
Vitamin D Deficiency - StatPearls - NCBI Bookshelf
Deficiency can lead to various complications, most notably rickets in children and osteoporosis in adults. Milk fortification with vitamin D in ...
Consensus Statement on Vitamin D Status Assessment and ...
Vitamin D deficiency and related secondary hyperparathyroidism cause bone loss and fractures in older adults. The incidence of hip fractures ...
The health effects of vitamin D supplementation: evidence ...
These data indicate that correction of severe vitamin D deficiency might improve bone density, but not when given to vitamin D-replete people.
Vitamin D deficiency: a worldwide problem with health ...
This study evaluated vitamin D2, which has been reported to be only 30% to 50% as effective as vitamin D3 in maintaining serum 25(OH)D concentrations (93, 94).
Safety Data Sheet
Trade name: Vitamin D3 Specific target organ toxicity (repeated exposure) 1 H372Causes damage to organs through prolonged or repeated exposure.
Cholecalciferol (Vitamin D3): MedlinePlus Drug Information
Cholecalciferol (Vitamin D3): learn about side effects, dosage, special precautions, and more on MedlinePlus.
Vitamin D
Safety and side effects · Upset stomach and vomiting. · Weight loss and not wanting to eat. · Muscle weakness. · Not being able to think clearly or quickly. · Heart ...
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sigmaaldrich.com
sigmaaldrich.com/US/en/sds/sial/phr1237?srsltid=AfmBOorTvbvmiy85P6bzq5LgJvp7FEimmzMp0Y3-Jeks4InSTlUn7VcMSAFETY DATA SHEET
OSHA: No component of this product present at levels greater than or equal to 0.1% is on OSHA's list of regulated carcinogens. Reproductive ...
Cholecalciferol - StatPearls - NCBI Bookshelf - NIH
Adverse Effects. Although cholecalciferol is generally considered safe, its adverse effects can occur due to high vitamin D levels.[39] High-loading doses of ...
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