Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary
History has shown that without explicit and enforced guidelines, even well-intentioned researchers can fail to adequately examine the ethical pros and cons of study design choices. One area in which consensus does not yet exist is the use of placebo groups in vitamin supplementation studies. As a pr...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2018-03-01
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| Series: | Nutrients |
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| Online Access: | http://www.mdpi.com/2072-6643/10/3/347 |
| _version_ | 1811229528243044352 |
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| author | Leigh A. Frame Jonathan P. Fischer Gail Geller Lawrence J. Cheskin |
| author_facet | Leigh A. Frame Jonathan P. Fischer Gail Geller Lawrence J. Cheskin |
| author_sort | Leigh A. Frame |
| collection | DOAJ |
| description | History has shown that without explicit and enforced guidelines, even well-intentioned researchers can fail to adequately examine the ethical pros and cons of study design choices. One area in which consensus does not yet exist is the use of placebo groups in vitamin supplementation studies. As a prime example, we focus on vitamin D research. We aim to provide an overview of the ethical issues in placebo-controlled studies and guide future discussion about the ethical use of placebo groups. Research in the field of vitamin D shows variation in how placebo groups are used. We outline four types of control groups 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 types highlight discrete ethical issues: active-control trials limit the ability to detect a difference; placebo-control trials that restrict supplementation potentially place subjects at risk of undue harm. The final two, placebo-control without supplementation restrictions or with rescue repletion therapy, offer potential solutions to these ethical challenges. Building on this, guidelines should be established and enforced on the use of placebo in supplementation studies. Furthermore, the field of vitamin D research has the potential to set an example worthy of emulation. |
| first_indexed | 2024-04-12T10:16:01Z |
| format | Article |
| id | doaj.art-6a31efb58764439591236873255eebaa |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-04-12T10:16:01Z |
| publishDate | 2018-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-6a31efb58764439591236873255eebaa2022-12-22T03:37:12ZengMDPI AGNutrients2072-66432018-03-0110334710.3390/nu10030347nu10030347Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical QuandaryLeigh A. Frame0Jonathan P. Fischer1Gail Geller2Lawrence J. Cheskin3The George Washington School of Medicine and Health Sciences, Washington, DC 20052, USAThe University of Chicago Pritzker School of Medicine, Chicago, IL 60637, USAThe Johns Hopkins School of Medicine, Baltimore, MD 21205, USAThe Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USAHistory has shown that without explicit and enforced guidelines, even well-intentioned researchers can fail to adequately examine the ethical pros and cons of study design choices. One area in which consensus does not yet exist is the use of placebo groups in vitamin supplementation studies. As a prime example, we focus on vitamin D research. We aim to provide an overview of the ethical issues in placebo-controlled studies and guide future discussion about the ethical use of placebo groups. Research in the field of vitamin D shows variation in how placebo groups are used. We outline four types of control groups 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 types highlight discrete ethical issues: active-control trials limit the ability to detect a difference; placebo-control trials that restrict supplementation potentially place subjects at risk of undue harm. The final two, placebo-control without supplementation restrictions or with rescue repletion therapy, offer potential solutions to these ethical challenges. Building on this, guidelines should be established and enforced on the use of placebo in supplementation studies. Furthermore, the field of vitamin D research has the potential to set an example worthy of emulation.http://www.mdpi.com/2072-6643/10/3/347nutrition therapydietary supplementsresearch ethicsresearch designvitamin D |
| spellingShingle | Leigh A. Frame Jonathan P. Fischer Gail Geller Lawrence J. Cheskin Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary Nutrients nutrition therapy dietary supplements research ethics research design vitamin D |
| title | Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary |
| title_full | Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary |
| title_fullStr | Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary |
| title_full_unstemmed | Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary |
| title_short | Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary |
| title_sort | use of placebo in supplementation studies vitamin d research illustrates an ethical quandary |
| topic | nutrition therapy dietary supplements research ethics research design vitamin D |
| url | http://www.mdpi.com/2072-6643/10/3/347 |
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