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Inositol for the prevention of neural tube defects: a pilot randomised controlled trial.
Br J Nutr. 2016 Mar 28; 115(6):974-83.BJ

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.

Authors+Show Affiliations

1Newlife Birth Defects Research Centre,Institute of Child Health,University College London,London WC1N 1EH,UK.1Newlife Birth Defects Research Centre,Institute of Child Health,University College London,London WC1N 1EH,UK.1Newlife Birth Defects Research Centre,Institute of Child Health,University College London,London WC1N 1EH,UK.1Newlife Birth Defects Research Centre,Institute of Child Health,University College London,London WC1N 1EH,UK.2Genetics, Genomics and Metabolism Programme,Institute of Child Health,University College London,London WC1N 1EH,UK.2Genetics, Genomics and Metabolism Programme,Institute of Child Health,University College London,London WC1N 1EH,UK.1Newlife Birth Defects Research Centre,Institute of Child Health,University College London,London WC1N 1EH,UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26847388

Citation

Greene, Nicholas D E., et al. "Inositol for the Prevention of Neural Tube Defects: a Pilot Randomised Controlled Trial." The British Journal of Nutrition, vol. 115, no. 6, 2016, pp. 974-83.
Greene ND, Leung KY, Gay V, et al. Inositol for the prevention of neural tube defects: a pilot randomised controlled trial. Br J Nutr. 2016;115(6):974-83.
Greene, N. D., Leung, K. Y., Gay, V., Burren, K., Mills, K., Chitty, L. S., & Copp, A. J. (2016). Inositol for the prevention of neural tube defects: a pilot randomised controlled trial. The British Journal of Nutrition, 115(6), 974-83. https://doi.org/10.1017/S0007114515005322
Greene ND, et al. Inositol for the Prevention of Neural Tube Defects: a Pilot Randomised Controlled Trial. Br J Nutr. 2016 Mar 28;115(6):974-83. PubMed PMID: 26847388.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Inositol for the prevention of neural tube defects: a pilot randomised controlled trial. AU - Greene,Nicholas D E, AU - Leung,Kit-Yi, AU - Gay,Victoria, AU - Burren,Katie, AU - Mills,Kevin, AU - Chitty,Lyn S, AU - Copp,Andrew J, Y1 - 2016/02/05/ PY - 2016/2/6/entrez PY - 2016/2/6/pubmed PY - 2016/7/22/medline KW - FA folic acid KW - Folic acid supplementation KW - Inositol KW - MRC Medical Research Council KW - NTD neural tube defects KW - Neural tube defects KW - PONTI Prevention of Neural Tube Defects by Inositol KW - Pregnancy supplements SP - 974 EP - 83 JF - The British journal of nutrition JO - Br. J. Nutr. VL - 115 IS - 6 N2 - 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. SN - 1475-2662 UR - https://www.unboundmedicine.com/medline/citation/26847388/Inositol_for_the_prevention_of_neural_tube_defects:_a_pilot_randomised_controlled_trial_ L2 - http://journals.cambridge.org/abstract_S0007114515005322 DB - PRIME DP - Unbound Medicine ER -