Review of Vitamin D research identifies ethical issues in placebo use

April 5, 2018, George Washington University
Credit: CC0 Public Domain

Since World War II, medical ethics in research studies involving human subjects have shifted significantly. Despite this important growth, ethical issues remain. Nutrition supplementation research does not have guidelines around the use of placebo groups in clinical trials, posing ethical issues.

A team led by Leigh Frame, PhD, MHS, director for the Integrative Medicine Program at the George Washington University School of Medicine and Health Sciences, published a review of this issue in Nutrients, where she looked at various studies in the developing field of D research.

"We developed this review with the goal of raising awareness and starting a discussion about the potential behind study design," said Frame. "When it comes to ethics in supplementation research, we have gotten comfortable with following the standards. Our team is questioning if the standards are actually enough."

The field of vitamin D research shows variation in how placebo groups are used. The team looked at four types of control groups currently in use: active control, placebo control with restrictions on supplementation, placebo control without supplementation restrictions, and placebo control with rescue repletion therapy.

The first two control groups highlight discrete ethical issues. Active control groups can limit the ability of the study to detect a meaningful effect of the supplement. Placebo control with restrictions limits supplementation, potentially placing subjects at risk in vitamin D deficient subjects. The last two controls offer potential solutions to these ethical challenges by allowing participants access to to potentially mitigate vitamin D deficiency.

The review concludes that there is a need to establish and enforce guidelines for ethics in supplementation research for the use of placebo groups and that vitamin D research can be a leading example as the field continues to grow.

Frame and her team suggest that before using a , investigators should deeply consider the ethical implications of placebos in their study design. The authors also recommend that journals and funding agencies request thorough justifications of use, especially in cases of known nutritional deficiency or in vulnerable populations.

"It's important to note that though we focused on vitamin D research for this review, that is just one example," Frame said. "This is applicable to any supplementation study, whether it be vitamins or protein."

Explore further: Vitamin D supplementation doesn't change lean mass, BMD

More information: Leigh Frame et al, Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary, Nutrients (2018). DOI: 10.3390/nu10030347

Related Stories

Vitamin D supplementation doesn't change lean mass, BMD

April 11, 2016
(HealthDay)—For postmenopausal women with vitamin D insufficiency completing a structured weight-loss program, vitamin D3 supplementation is not associated with changes in lean mass or bone mineral density (BMD), according ...

Vitamin D supplements may benefit children with Autism Spectrum Disorder

November 21, 2016
Vitamin D supplementation improved symptoms of autism in a recent trial.

Vitamin D shows no impact on interferon response in SLE

July 10, 2015
(HealthDay)—For patients with systemic lupus erythematosus (SLE), vitamin D3 supplementation does not affect interferon (IFN) signature, according to a study published in the July issue of Arthritis & Rheumatology.

Calcium, vitamin D don't seem to reduce fracture risk in seniors

December 27, 2017
(HealthDay)—For community-dwelling older adults, supplementation with calcium, vitamin D, or both does not reduce the incidence of fractures, according to a review published in the Dec. 26 issue of the Journal of the American ...

Monthly high-dose vitamin D supplementation does not prevent cardiovascular disease

April 5, 2017
Results of a large randomized trial indicate that monthly high-dose vitamin D supplementation does not prevent cardiovascular disease, according to a study published by JAMA Cardiology.

Vitamin D doesn't impact insulin sensitivity, secretion in T2DM

May 10, 2017
(HealthDay)—For patients with type 2 diabetes (T2D) and vitamin D deficiency, vitamin D supplementation has no impact on insulin sensitivity or secretion, according to a study published online May 3 in Diabetes Care.

Recommended for you

New research suggests possible link between sudden infant death syndrome and air pollution

April 20, 2018
A study led by the University of Birmingham suggests a possible association between exposure to certain pollutants and an increased risk of so-called 'cot death'.

For heavy lifting, use exoskeletons with caution

April 20, 2018
You can wear an exoskeleton, but it won't turn you into a superhero.

Low total testosterone in men widespread, linked to chronic disease

April 19, 2018
A male's total testosterone level may be linked to more than just sexual health and muscle mass preservation, a new study finds. Low amounts of the hormone could also be associated with chronic disease, even among men 40 ...

New device to help patients with rare disease access life-saving treatment

April 19, 2018
Patients with a rare medical condition can receive life-saving treatment at the touch of a button thanks to a new device developed by scientists.

Low-cost anti-hookworm drug boosts female farmers' physical fitness

April 19, 2018
Impoverished female farm workers infected with intestinal parasites known as hookworms saw significant improvements in physical fitness when they were treated with a low-cost deworming drug. The benefits were seen even in ...

Age affects how we predict and respond to stress at home

April 19, 2018
A recent study finds that older adults are better than younger adults at anticipating stressful events at home - but older adults are not as good at using those predictions to reduce the adverse impacts of the stress.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.