Drawing criticism from industry stakeholders, the U.S. Preventive Services Task Force (USPSTF) has recommended against daily supplementation of vitamin D and calcium for the primary prevention of fractures in postmenopausal women.

In a statement the USPSTF concluded the following:

• “The current evidence is insufficient to assess the balance of the benefits and harms of combined vitamin D and calcium supplementation for the primary prevention of fractures in premenopausal women or in men.”

• “The current evidence is insufficient to assess the balance of the benefits and harms of daily supplementation with greater than 400 IU of vitamin D3 and greater than 1,000 mg of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women.”

• “The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D3 and 1,000 mg or less of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women.”

Dr. Cara Welch, senior vice president of scientific and regulatory affairs, with the Natural Products Association (NPA), Washington, D.C., said the association believes “dietary supplementation is both safe and effective for anyone who isn’t getting enough calcium and vitamin D from their diet. These nutrients have been shown to support bone health and it’s important that consumers get the recommended levels of both. If diet alone isn’t enough, then dietary supplements can help with getting these vital nutrients.”

USPSTF stated that supplementation has not been proven beneficial and carries a small risk. According to Dr. Welch, “this conflicts with the recommendation of the Institute of Medicine, which took into account nearly 1,000 published studies that confirm the role of calcium and vitamin D supplements in promoting bone health.”

“The statement by the task force is contradicted by current research and may prove harmful to women at risk of fractures. Studies continue to show the beneficial effects of calcium and vitamin D supplements. As always, NPA recommends that consumers discuss their nutritional needs with their healthcare professional.”

The Council for Responsible Nutrition (CRN), Washington, D.C., said the recommendation represents a “limited review of the literature” and could result in “widespread confusion for consumers who already are not getting enough calcium, and who further could benefit from the growing body of research that demonstrates multiple reasons to take vitamin D.”

According to CRN’s Taylor Wallace, PhD, senior director, scientific and regulatory affairs, “These recommendations fail to recognize the well-established role of calcium and vitamin D in maintaining bone health. If these recommendations are taken to heart, or misconstrued as general recommendations against calcium and vitamin D, consumers could be compromising their bone health and missing out on important other benefits from these nutrients. The bottom line: calcium and vitamin D are vital to staying healthy.”

These recommendations are not the first controversial conclusions to come out of USPSTF. Previously, the same organization recommended against both routine mammography screenings in women under 50 and breast self-examinations, as well as prostate cancer screenings for men, putting them at odds with many in the medical community. “These kinds of preventative measures help save lives, and similarly, taking calcium and vitamin D are valuable preventative measures that provide a variety of health benefits, despite the outcome of one meta-analysis,” Dr. Wallace said.

The USPSTF’s meta-analysis was heavily reliant on the Women’s Health Initiative (WHI), the largest randomized controlled trial of calcium and vitamin D supplementation, which showed little to no effect on fracture rates in the more than 35,000 postmenopausal women in the trial. However, many of the women in the treatment group were not adhering to their calcium regimen. Investigators also discovered that women in the placebo group were actually getting close to the IOM’s recommended levels for calcium on their own, making it difficult for the treatment group to demonstrate benefit. These limitations of the WHI are now widely acknowledged, but were ignored by the USPSTF, CRN said.

Despite the limitations in the original study, a recent 2013 study by the WHI investigators reanalyzed the data, looking specifically at those women who strictly adhered to the calcium/vitamin D protocol. These results showed a significant 38% reduction in hip fracture and no increased incidence of kidney stone development. The results of this latest study were not included in the USPSTF meta-analysis. Dr. Wallace noted, “The results of this latest re-analysis of the WHI data are extremely compelling.”

The USPSTF recommendations should be further reviewed and discussed within the scientific and medical communities before consumers jump to change their supplementation habits, CRN added. When considering dietary supplements, consumers also need to take their individual needs and food intakes into account. 

CRN’s Duffy MacKay, ND, vice president, scientific and regulatory affairs, advised, “Keep a food diary, so you know what nutrients you’re getting from your food, then consider adding calcium supplements to get what you need, based on your life stage and lifestyle. Vitamin D is harder to get from food, but it’s still important to know what your intake is; have your vitamin D levels tested by your doctor through a simple blood test. Make sure you’re communicating with your doctor, nurse practitioner or registered dietitian, whichever professional you rely on for your health decisions.”

Dr. MacKay continued, “But consumers also shouldn’t be looking for magic bullets to prevent bone fractures. Instead, they should practice a combination of healthy habits, which include a role for supplements along with strength conditioning and good diet.”