HealthDay News — Dietary supplement (DS) use is common in the US, according to a study published online April 18 in the National Health Statistics Reports, a publication from the US Centers for Disease Control and Prevention.

Suruchi Mishra, PhD, from the National Center for Health Statistics in Hyattsville, Maryland, and colleagues present prevalence estimates for DS use using data from the 2017 to March 2020 prepandemic National Health and Nutrition Examination Survey (NHANES) for children and adolescents aged 0 to 19 years and adults aged 20 years and older (6324 and 9924 individuals, respectively).

The researchers found that 34.8% of children and adolescents and 58.5% of adults used at least one DS in the past 30 days during 2017 to March 2020. Except for children aged 12 to 24 months, use was higher among females than males. Among adults, DS use increased with income and education. Higher DS use was reported among non-Hispanic Asian and non-Hispanic White adults than Hispanic and non-Hispanic Black adults. Among adults, use of multiple DSs increased with age. Overall, 23.5 and 31.5% of youth and adults, respectively, reported use of a multivitamin mineral, while 3.0 and 18.5%, respectively, reported vitamin D use. Most adults using a multivitamin mineral or vitamin D reported daily use.

“These results indicate that any DS and multiple DS intake is common in the United States, and national surveys, such as NHANES, should continue to monitor DS use among children, adolescents, and adults,” the authors write.

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The Food and Drug Administration (FDA) has approved a shelf life extension for certain lots of CMP Pharma’s Potassium Phosphates Injection in order to mitigate drug shortage concerns.

CMP Pharma’s Potassium Phosphates Injection is a phosphorus replacement product indicated as a source of phosphorus in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. It is also approved for parenteral nutrition in adults weighing at least 45kg and pediatric patients 12 years of age and older weighing at least 40kg when oral or enteral nutrition is not possible, insufficient or contraindicated.

The new extended use dates for CMP Pharma’s Potassium Phosphates Injection (phosphorus 45mmol/15mL [3mmol/mL] and potassium 71mEq/15mL [4.7mEq/mL]) include:

• NDC Number 46287-024-10 (cartons) and NDC Number 46287-024-15 (individual vials)
  • Lot# CR31; Expiration Date (labeled) June 2023; Extended Use Date December 2023
  • Lot# CR86; Expiration Date (labeled) June 2023; Extended Use Date December 2023
  • Lot# CS86; Expiration Date (labeled) October 2023; Extended Use Date April 2024
  • Lot# CS89; Expiration Date (labeled) October 2023; Extended Use Date April 2024
  • Lot# CS96; Expiration Date (labeled) October 2023; Extended Use Date April 2024
  • Lot# CT36; Expiration Date (labeled) November 2023; Extended Use Date May 2024
  • Lot# CT40; Expiration Date (labeled) November 2023; Extended Use Date May 2024

The Food and Drug Administration (FDA) has issued a safety alert regarding the use of unapproved potassium phosphates drug products in pediatric patients, specifically those manufactured by Hospira.

Potassium phosphates injection is a phosphorus replacement product indicated as a source of phosphorus in intravenous fluid to correct hypophosphatemia and for parenteral nutrition. In pediatric patients, use of Hospira’s potassium phosphates drug product may result in daily aluminum exposures of up to twice the recommended limit for parenteral nutrition.

According to the FDA, the total allowable aluminum exposure from parenteral nutrition should not exceed 5mcg/kg/day. Exposure to toxic levels of aluminum can result in osteomalacia, reduced bone mineralization, neurological dysfunction, microcytic hypochromic anemia, and cholestasis.

Products with an aluminum content level considered acceptable for each patient based on age, weight, and recommended dose of phosphorus include Fresenius Kabi’s Potassium Phosphates Injection and CMP Development’s Potassium Phosphates Injection.  

The FDA has requested that Hospira update the labeling for its potassium phosphates product to state that it is not recommended in pediatric patients because of aluminum toxicity.

Reference

US Food and Drug Administration. Infants at risk for aluminum toxicity with unapproved potassium phosphates drug product. Accessed February 9, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/infants-risk-aluminum-toxicity-unapproved-potassium-phosphates-drug-product.

However, patients who took high doses of multivitamins had a higher risk of cancer-specific death. The researchers reported these findings in Cancer.

The study included data from 2424 patients with stage I-III CRC who were enrolled in the Nurses’ Health Study and the Health Professionals Follow-up Study.

Over a median follow-up of 11 years, there were 1512 deaths, and 343 of those deaths were considered related to CRC. Other causes of death included cardiovascular diseases (n=330), cancers other than CRC (n=209), dementia (n=116), and respiratory disease (n=104).

In a multivariable analysis, CRC patients who reported taking 3 to 5 multivitamin tablets per week after their diagnosis had a significantly lower risk of CRC-specific death than patients who did not take multivitamins (hazard ratio [HR], 0.55; 95% CI, 0.36-0.83; P =.005).

Patients who took 3 to 5 tablets also had a lower risk of all-cause death (HR, 0.81; 95% CI, 0.67-0.99; P =.04), as did patients who took 6 to 9 tablets per week (HR, 0.79; 95% CI, 0.70-0.88; P <.001).

However, patients who took 10 or more multivitamin tablets per week had a higher risk of CRC‐specific death than patients who did not take multivitamins (HR, 1.60; 95% CI, 1.07-2.40, P =.02).

There were no other significant associations for patients in the aforementioned dose groups or for patients who took 1 to 2 multivitamin tablets per week. The researchers noted that patients who took 3 to 5 tablets per week had the maximum reduction in mortality risk.

“Users taking more than 8 tablets/week tended to have a higher risk of CRC‐specific mortality, and users with more than 10 tablets/week had a significantly higher risk of CRC‐specific mortality than non‐[users],” the researchers wrote. “These findings suggest that a dose at 3–5 tablets/week may be considered in future clinical trials to further confirm our results.”

The researchers noted that this study has limitations, including recall bias, residual confounding, and a lack of detailed information about treatments.

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Although previous findings have linked regular salt consumption to an increased risk for hypertension and cardiovascular disease, the association between salt intake and type 2 diabetes remains unclear.

Researchers conducted the population-based, prospective cohort UK Biobank study to evaluate the association between salt consumption and the development of type 2 diabetes. Participants were aged 37 to 73 years and recruited from 22 different assessment centers across the United Kingdom between 2006 and 2010.

Participants completed nurse-administered questionnaires regarding demographics, health data, and food frequency. Exclusion criteria included type 2 diabetes, cardiovascular disease, cancer, and impaired kidney function at baseline.

The researchers used Cox proportional hazard regression to estimate hazard ratios of type 2 diabetes in relation to frequency of salt consumption. Salt consumption was stratified as (1) never/rarely, (2) sometimes, (3) usually, and (4) always. Subgroup analyses were stratified by age, sex, smoking status, alcohol intake, physical activity, and diet quality.

The numbers of patients in each stratum of salt consumption were:

• 204,831 (mean age, 55.7 years; SD, 8.1; never/rarely);
• 103,286 (mean age, 55.6 years; SD, 8.1; sometimes);
• 42,348 (mean age, 56.2; SD, 8.0; usually);
• 17,283 (mean age, 55.0; SD, 8.2; always). 

Compared with participants who never/rarely added salt to foods, those who preferred adding salt to meals were more likely to be non-White, be socioeconomically disadvantaged, consume alcohol, smoke, exercise less, have an unhealthy diet, and have increased hemoglobin A1c levels. 

The researchers identified a total of 10,981 type 2 diabetes cases during a median follow-up of 12.6 years. The adjusted hazard ratios (HRs) for each stratum, compared with participants who never/rarely added salt to foods (P <.001), were:

• 1.07 (95% CI, 1.03-1.12; sometimes);
• 1.09 (95% CI, 1.03-1.16; usually); and,
• 1.28 (95% CI, 1.19-1.38; always).

In an analysis of the association between genetic susceptibility and incident type 2 diabetes, the researchers found increased risks for type 2 diabetes among participants in the highest tertile (HR, 2.34; 95% CI, 2.22 to 2.48) and second highest tertile (HR, 1.49; 95% CI, 1.41 to 1.58) of genetic risk scores compared with those in the lowest tertile (P <.001).

Genetic susceptibility to type 2 diabetes was correlated with the frequency of adding salt to food, but this relationship was not statistically significant. 

Study limitations include the potential of residual confounding bias, the inability to depict dose-dependent relationships between salt frequency and type 2 diabetes, and the lack of generalizability due to better socioeconomic status among study participants compared with the general UK population.

The researchers concluded, “[T]he frequency of adding salt to foods was associated with a gradually elevated risk of incident type 2 diabetes among the UK Biobank participants, independent of their genetic predisposition to type 2 diabetes.” 

Meng Chen and Victor W. Zhong, PhD, from Shanghai Jiao Tong University, examined whether TRE is associated with a reduced risk for all-cause and cause-specific mortality in a cohort of participants aged at least 20 years who completed 2 valid 24-hour dietary recalls. Typical eating duration was categorized as less than 8, 8 to less than 10, 10 to less than 12, 12 to 16 (reference group), and greater than 16 hours.

Data were included for 20,078 adults (weighted mean age, 48.5 years). The researchers identified 2797 all-cause deaths during a median follow-up of 8.0 years, including 840 and 643 cardiovascular and cancer deaths, respectively. Eating duration of less than 8 hours was significantly associated with an increased risk for cardiovascular mortality compared with an eating duration of 12 to 16 hours (hazard ratio, 1.96); the association was also seen for adults with cardiovascular disease and adults with cancer (hazard ratios, 2.06 and 2.72, respectively). No other eating durations were associated with cardiovascular mortality, apart from an eating duration of 8 to less than 10 hours for those with cardiovascular disease (hazard ratio, 1.64).

“It’s crucial for patients, particularly those with existing heart conditions or cancer, to be aware of the association between an 8-hour eating window and increased risk of cardiovascular death,” Zhong said in a statement. “Our study’s findings encourage a more cautious, personalized approach to dietary recommendations.”

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HealthDay News — The US Preventive Services Task Force (USPSTF) recommends folic acid supplementation for people planning to or who could become pregnant. These recommendations form the basis of a final recommendation statement published in the August 1 issue of the Journal of the American Medical Association.

Meera Viswanathan, PhD, from RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center, and colleagues conducted a systematic review of the new evidence on the benefits and harms of folic acid supplementation for prevention of neural tube defects. Data were included from 12 observational studies reported in 13 publications, with 1,244,072 participants. The researchers found that one cohort study reported a significantly reduced risk for neural tube defects associated with folic acid supplementation taken before, during, and before and during pregnancy (adjusted relative risks, 0.54, 0.62, and 0.49, respectively); this association was seen in the later of 2 study periods (2006 to 2013 but not 1999 to 2005). No other significant benefits were reported. There were no reports of significant harms associated with pregnancy-related folic acid exposure.

Based on these findings, the USPSTF concludes there is a high certainty that folic acid supplementation has a substantial net benefit for preventing neural tube defects in offspring. Consequently, the USPSTF recommends a daily supplement containing 0.4 to 0.8 mg of folic acid for all persons planning to or who could become pregnant (A recommendation).

“The Task Force continues to underscore the importance of taking a daily supplement containing folic acid before and during early pregnancy to help protect the health of babies,” task force member Katrina Donahue, MD, MPH, said in a statement.

Evidence Report

Final Recommendation Statement

Editorial 1 (subscription or payment may be required)

Editorial 2 (subscription or payment may be required)