Pregnant Women's Dietary Supplement Use New NIH Focus

The National Institutes of Health will sponsor a conference in January on dietary supplement use by women of reproductive age.

Still in the early planning stages, the meeting's specific NIH sponsors have not yet been determined, although the National Center for Complementary & Alternative Medicine and the Office of Dietary Supplements likely will be on the list.

NIH said the decision to hold the gathering was spurred by a February conference on supplement use by children (¹ (Also see "Pediatric Dietary Supplement Trials Needed To Set Standards Of Care" - Pink Sheet, 19 Feb, 2001.)).

Issues related to dietary supplement use by pregnant women and accompanying safety questions also were tackled at an FDA public meeting last March (² ).

The Consumer Healthcare Products Association filed a citizen petition with the agency in May 2000 proposing labeling statements for supplements with insufficient data supporting their safe use in pregnant women. The statement would read: "If you are pregnant or nursing a baby, ask a healthcare professional."

The January conference might be just one of many outgrowths of the earlier NIH-sponsored children's meeting.

Following the February seminar, a follow-up session was held with representatives from the Nutrition Coordinating Committee, National Institute of Child Health & Human Development, ODS, National Cancer Institute, National Institute of Diabetes & Digestive & Kidney Diseases, FDA and a scientific steering committee.

Reviewing the topics discussed at this follow-up session, Daniel Raiten, PhD, with NICHD's Office of Prevention Research & International Programs, reviewed NIH's top priorities with regard to children's use of dietary supplements at the Pediatric Academic Societies' annual meeting in Baltimore May 1.

Better utilization of national survey data, more extensive training for staff members with regard to pediatric research and dietary supplements and the development of better surveillance methodologies to track children's supplement use all were suggested, Raiten said.

Attendees at the follow-up session also began to outline a potential research agenda, with teenagers' use of performance-enhancing supplements a topic many believe needs further study, Raiten said.

Also speaking at the PAS meeting, Mark Davis, PhD, University of South Carolina, noted certain parameters should be followed when studying performance-enhancing products.

For example, Davis maintained such trials should examine athletic individuals who are well trained, since all non-athletic individ-uals would see improvement undergoing a physical workout.

Using repeated measures or a cross-over design also is important when testing a supplement in the same group of people, Davis said. He pointed to design problems in earlier trials, saying most studies of performance-enhancing supplements have consisted of small sample sizes and lacked randomization.

A number of variables must be controlled as well, including diet, exercise, performance and body composition, Davis pointed out.

He concluded by emphasizing fluid and carbohydrates are the primary nutrition products athletes should use, while "most of the other supplements should be left alone."

Deirdre Bernard-Pearl, MD, University of California at San Francisco, reviewed the use of certain botanicals by young children and infants.

Young children particularly are prone to electrolyte disturbances, she said, emphasizing parents should be wary of administering "anything that would be a potent laxative," including high doses of aloe and senna.

Children should avoid black tea because it contains tannins, which block iron absorption. Supplements with honey also pose a threat to children less than one year old, as honey can cause infant botulism - a potentially fatal ailment, she said.

Although young children's use of dietary supplements, such as probiotics, has risen considerably, Bernard-Pearl concluded that potential "toxicity warrants further study."