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However, the efficacy of vitamin D supplementation in reducing the occurrence of preeclampsia remains unclear. The objective of this study was to evaluate the effect of cholecalciferol supplementation on the incidence of preeclampsia in primigravid women and its related maternal and foetal outcomes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A single-blinded clinical trial was conducted in fourteen antenatal care health facilities in the North (Goma, Mwesso, Nyiragongo)\u00a0and South Kivu\u00a0(Bukavu-Panzi) provinces of the Democratic Republic of Congo from March 1, 2020, to June 30, 2021. A total of 1300 primigravid women not exceeding 16\u00a0weeks of gestation were randomised with a 1:1 ratio to either the supplemented (A) or control (B) group. Each pregnant woman (A) presenting for antenatal care received a single monthly dose of cholecalciferol (60,000\u00a0IU) orally for 6\u00a0months. The control group received no vitamin D supplementation or placebo. Serum 25(OH)D was measured at recruitment and at 34\u00a0weeks of gestation. Outcomes were assessed monthly until delivery.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The median maternal age was 21\u00a0years (14\u201340), while the median gestational age was 15\u00a0weeks (5.4\u201329.0). A significant reduction in the risk of preeclampsia [RR\u2009=\u20090.36 (0.19\u20130.69); <jats:italic>p<\/jats:italic>\u2009=\u20090.001] and preterm delivery [RR\u2009=\u20090.5 (0.32\u20130.78); <jats:italic>p<\/jats:italic>\u2009=\u20090.002] was observed in the intervention group. An RR of 0.43 [(0.27\u20130.67); <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001] was found for low birth weight. The RR for caesarean section was 0.63 [(0.52\u20130.75); <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001]. The APGAR score at the 5th minute (<jats:italic>p<\/jats:italic>\u2009=\u20090.021) and the size of the newborn were significantly higher in the supplemented group (<jats:italic>p<\/jats:italic>\u2009=\u20090.005).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>A single monthly dose (60,000\u00a0IU) of vitamin D supplementation, started in earlypregnancy, significantly reduced the incidence of preeclampsia and its maternal and foetal complications.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ISRCTN Register with ISRCTN46539495 on 17 November 2020.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12884-024-06277-6","type":"journal-article","created":{"date-parts":[[2024,2,3]],"date-time":"2024-02-03T09:02:09Z","timestamp":1706950929000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Effect of early vitamin D supplementation on the incidence of preeclampsia in primigravid women: a randomised clinical trial in Eastern Democratic Republic of the Congo"],"prefix":"10.1186","volume":"24","author":[{"given":"Richard Kabuseba","family":"Kabuyanga","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierrot Lundimu","family":"Tugirimana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Balungwe","family":"Sifa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mwanga","family":"Balezi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel Ekanga","family":"Dikete","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prudence Ndeba","family":"Mitangala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean Pierre Moyene","family":"Elongi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier Kalume","family":"Kinenkinda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Baptiste Sakatolo Zambeze","family":"Kakoma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,2,3]]},"reference":[{"issue":"2","key":"6277_CR1","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1097\/GCO.0b013e32835e0ef5","volume":"25","author":"JO Lo","year":"2013","unstructured":"Lo JO, Mission JF, Caughey AB. 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The purpose of the study was communicated in the local language to eligible women. Oral and written informed consent was obtained from all participants. The research project was approved by the Institutional Review Board of the University of Lubumbashi in its February 8, 2019 session (Reference N\u00b0 UNILU\/CEM\/125\/2019). In addition, the study was authorised by the provincial health division of North Kivu.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"107"}}