Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial

• Published in: International journal of environmental research and public health Vol. 17; no. 21; p. 8023
• Main Authors: Rodrigues Amorim Adegboye, Amanda, Dias Santana, Danilo, Cocate, Paula Guedes, Benaim, Camila, Teixeira Dos Santos, Pedro Paulo, Heitmann, Berit Lilienthal, da Veiga Soares Carvalho, Maria Cláudia, Schlüssel, Michael Maia, Trindade de Castro, Maria Beatriz, Kac, Gilberto
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 30.10.2020; MDPI
• Subjects: Acceptability; Animals; Brazil; Calciferol; Calcium; Calcium Carbonate; Childbirth & labor; Content analysis; Data collection; Dentists; Diabetes; Feasibility Studies; Female; Focus groups; Food, Fortified; Gum disease; Humans; Intervention; Milk; Participation; Periodontitis; Periodontitis - therapy; Placebos; Pregnancy; Pregnancy Complications - therapy; Pregnant Women; Qualitative analysis; Retention; Statistical analysis; Vitamin D; Vitamin D - therapeutic use; Vitamins - therapeutic use; Womens health; Brazil; feasibility; adherence; pregnancy; attrition rate; periodontal therapy; milk fortification; acceptability
• ISSN: 1660-4601; 1661-7827; 1660-4601
• DOI: 10.3390/ijerph17218023

This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca+VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.