eprintid: 1476433 rev_number: 26 eprint_status: archive userid: 608 dir: disk0/01/47/64/33 datestamp: 2016-03-11 16:05:14 lastmod: 2021-12-13 02:18:11 status_changed: 2016-03-11 16:05:14 type: article metadata_visibility: show creators_name: Greene, ND creators_name: Leung, KY creators_name: Gay, V creators_name: Burren, K creators_name: Mills, K creators_name: Chitty, LS creators_name: Copp, AJ title: Inositol for the prevention of neural tube defects: a pilot randomised controlled trial ispublished: pub divisions: UCL divisions: B02 divisions: D13 divisions: G22 divisions: G23 keywords: FA folic acid, Folic acid supplementation, Inositol, MRC Medical Research Council, NTD neural tube defects, Neural tube defects, PONTI Prevention of Neural Tube Defects by Inositol, Pregnancy supplements note: Copyright © The Authors 2016 This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. abstract: Although peri-conceptional folic acid (FA) supplementation can prevent a proportion of neural tube defects (NTD), there is increasing evidence that many NTD are FA non-responsive. The vitamin-like molecule inositol may offer a novel approach to preventing FA-non-responsive NTD. Inositol prevented NTD in a genetic mouse model, and was well tolerated by women in a small study of NTD recurrence. In the present study, we report the Prevention of Neural Tube Defects by Inositol (PONTI) pilot study designed to gain further experience of inositol usage in human pregnancy as a preliminary trial to a future large-scale controlled trial to evaluate efficacy of inositol in NTD prevention. Study subjects were UK women with a previous NTD pregnancy who planned to become pregnant again. Of 117 women who made contact, ninety-nine proved eligible and forty-seven agreed to be randomised (double-blind) to peri-conceptional supplementation with inositol plus FA or placebo plus FA. In total, thirty-three randomised pregnancies produced one NTD recurrence in the placebo plus FA group (n 19) and no recurrences in the inositol plus FA group (n 14). Of fifty-two women who declined randomisation, the peri-conceptional supplementation regimen and outcomes of twenty-two further pregnancies were documented. Two NTD recurred, both in women who took only FA in their next pregnancy. No adverse pregnancy events were associated with inositol supplementation. The findings of the PONTI pilot study encourage a large-scale controlled trial of inositol for NTD prevention, but indicate the need for a careful study design in view of the unwillingness of many high-risk women to be randomised. date: 2016-03-01 date_type: published official_url: http://dx.doi.org/10.1017/S0007114515005322 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green article_type_text: Journal Article verified: verified_manual elements_id: 1108673 doi: 10.1017/S0007114515005322 pii: S0007114515005322 language_elements: eng lyricists_name: Chitty, Lyn lyricists_name: Copp, Andrew lyricists_name: Greene, Nicholas lyricists_name: Leung, Kit-Yi lyricists_name: Mills, Kevin lyricists_id: LCHIT39 lyricists_id: ACOPP78 lyricists_id: NDEGR34 lyricists_id: KYLEU59 lyricists_id: KMILL65 actors_name: Barczynska, Patrycja actors_id: PBARC91 actors_role: owner full_text_status: public publication: British Journal of Nutrition volume: 115 number: 6 pagerange: 974-983 event_location: England issn: 1475-2662 citation: Greene, ND; Leung, KY; Gay, V; Burren, K; Mills, K; Chitty, LS; Copp, AJ; (2016) Inositol for the prevention of neural tube defects: a pilot randomised controlled trial. British Journal of Nutrition , 115 (6) pp. 974-983. 10.1017/S0007114515005322 <https://doi.org/10.1017/S0007114515005322>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/1476433/1/S0007114515005322a.pdf