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

ABSTRACT: 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.

SUBMITTER: Rodrigues Amorim Adegboye A

PROVIDER: S-EPMC7662458 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Rodrigues Amorim Adegboye Amanda A Dias Santana Danilo D Cocate Paula Guedes PG Benaim Camila C Teixeira Dos Santos Pedro Paulo PP Heitmann Berit Lilienthal BL da Veiga Soares Carvalho Maria Cláudia MC Schlüssel Michael Maia MM Trindade de Castro Maria Beatriz MB Kac Gilberto G

International journal of environmental research and public health 20201030 21

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 p ...[more]

PMID: 33143369

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Project description:BackgroundPeriodontitis is a common oral inflammation, which is a risk factor for adverse pregnancy outcomes. Intakes of vitamin D and calcium are inversely associated with occurrence and progression of periodontitis. This study aims to assess the feasibility of a multi-component intervention, including provision of milk powder supplemented with calcium and vitamin D and periodontal therapy (PT), for improving maternal periodontal health and metabolic and inflammatory profiles of low-income Brazilian pregnant women with periodontitis.MethodsThe IMPROVE trial is a feasibility randomised controlled trial (RCT) with a 2 × 2 factorial design with a parallel process evaluation. Pregnant women with periodontitis, aged 18-40 years and with < 20 gestational weeks (n = 120) were recruited and randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus PT during pregnancy, (2) placebo sachet and powdered milk plus PT during pregnancy, (3) fortified sachet (vitamin D and calcium) and powdered milk plus PT after delivery and (4) placebo sachet and powdered milk plus PT after delivery. Dentists and participants are blinded to fortification. Acceptability of study design, recruitment strategy, random allocation, data collection procedures, recruitment rate, adherence and attrition rate will be evaluated. Data on serum levels of vitamin D, calcium and inflammatory biomarkers; clinical periodontal measurements; anthropometric measurements; and socio-demographic questionnaires are collected at baseline, third trimester and 6-8 weeks postpartum. Qualitative data are collected using focus group, for analysis of favourable factors and barriers related to study adherence.DiscussionOral health and mineral/vitamin supplementation are much overlooked in the public prenatal assistance in Brazil and of scarcity of clinical trials addressing these issues in low and middle-income countries,. To fill this gap the present study was designed to assess the feasibility of a RCT on acceptability of a multi-component intervention combining conventional periodontal treatment and consumption of milk fortified with calcium-vitamin D for improving periodontal conditions and maternal metabolic and inflammation status, among Brazilian low-income pregnant women with periodontitis. Thus, we hope that this relatively low-cost and safe multicomponent intervention can help reduce inflammation, improve maternal periodontal health and metabolic profile and consequently prevent negative gestational outcomes.Trial registrationNCT, NCT03148483. Registered on May 11, 2017.

Project description:BACKGROUND:Micronutrient deficiency affects the health and development of vulnerable population such as children and pregnant women. Measures such as fortification of food and supplementation have been implemented to prevent or control deficiencies related to micronutrients. OBJECTIVE:To assess the effect of vitamin A, vitamin D, and calcium fortification and supplementation on nutritional status of women in reproductive age group. To assess the toxicities and adverse events related to intervention. METHODOLOGY:Systematic reviews including RCTs on women of reproductive age group provided with vitamin A, vitamin D, and calcium supplementation or fortified food were included, to report all malnutrition-related outcomes due to deficiency of the abovementioned micronutrients. The Cochrane Database of Systematic Reviews, EPPI Centre, Campbell Collaboration, PubMed, Web of Science, and Scopus were searched electronically for English language publications, until 31 March 2018. Hand searching of the articles was done from the Journal of Food Science and Technology. Two independent reviewers selected the systematic reviews, extracted data, and assessed for the quality. RESULTS:A total of 16 systematic reviews were included in narrative synthesis. Supplementation of vitamin A was reported to result in increased maternal serum retinol concentrations and increased breast milk retinol concentration. It reduced the risk of anemia (Hb < 11?g/dL) and reduced maternal clinical infection. Vitamin D supplementation increased 25-hydroxy vitamin D levels. There was insufficient evidence for the effect on bone mineral density and serum calcium levels. Calcium supplementation did not have any significant effect on body weight, weight gain, and body mass index of the participants. CONCLUSION:This overview of systematic reviews reiterates the nutritional importance of vitamin A, vitamin D, and calcium supplementation for the reproductive age women. However, there was no empirical evidence available for fortification of food with vitamin A, vitamin D, and calcium and nutritional benefits of the same for reproductive age women, therefore thrusting upon the need of conducting future quality research, i.e., clinical trials and systematic reviews for food fortification. SYSTEMATIC REVIEW REGISTRATION:A priori protocol for this overview of systematic reviews was registered in PROSPERO with registration number CRD42018089403 .

Project description:Vitamin D plays a central role in calcium homeostasis; however, its relationship with bone turnover during pregnancy remains unclear due to a lack of studies that have rigorously controlled for vitamin D and other nutrients known to influence bone metabolism. Similarly, prior investigations of the effect of pregnancy on bone turnover relative to the nonpregnant state may have been confounded by varying intakes of these nutrients. Nested within a controlled intake study, the present investigation sought to quantify associations between maternal vitamin D biomarkers and biochemical markers of bone turnover among pregnant (versus nonpregnant) women and their fetuses under conditions of equivalent and adequate intakes of vitamin D and related nutrients. Changes in markers of bone turnover across the third trimester were also examined. Healthy pregnant (26-29 wk gestation; n=26) and nonpregnant (n=21) women consumed 511IU vitamin D/d, 1.6g calcium/d, and 1.9g phosphorus/d for 10weeks while participating in a controlled feeding study featuring two choline doses. Based on linear mixed models adjusted for influential covariates (e.g., BMI, ethnicity, and season), pregnant women had 50-150% higher (P<0.001) concentrations of bone resorption markers than nonpregnant women. Among pregnant women, increases in maternal 25(OH)D across the study period were associated (P<0.020) with lower osteocalcin and deoxypyridinoline at study-end, and higher fetal osteocalcin. In addition, maternal free 25(OH)D, 1,25(OH)2D and 24,25(OH)2D tended to be negatively associated (P?0.063) with maternal NTx at study-end, and maternal free 25(OH)D and 24,25(OH)2D were positively associated (P?0.021) with fetal CTx. Similarly, maternal 3-epi-25(OH)D3 was negatively related (P?0.037) to maternal NTx and deoxypyridinoline at study-end. These declines in bone resorption markers resulting from higher vitamin D biomarker concentrations among pregnant women coincided with increases in their albumin-corrected serum calcium concentrations, indicating that calcium transfer to the fetus was uncompromised. Notably, none of these associations achieved statistical significance among nonpregnant women. Overall, our study findings suggest that achieving higher maternal concentrations of vitamin D biomarkers might attenuate third-trimester bone resorption while ensuring sufficient calcium delivery to the fetus.

Dataset Information

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

Publications

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

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