Table 2 Inclusion and exclusion criteria for the IMPROVE feasibility trial
Inclusion criteria | Exclusion criteria |
|---|---|
1. Aged ≥ 18 years at the time of recruitment | 1. Positive diagnosis of HIV/AIDS, syphilis, psychosis, diabetes before pregnancy, thyroid disease, or any disorder causing vitamin D hypersensitivity (e.g. sarcoidosis and other lymphomatous disorders) |
2. > 20 weeks gestation at first prenatal visit | 2. Lactose intolerance, milk allergy, history of renal stones or family history of renal stone and hyperparathyroidism |
3. Positive diagnosis of periodontitis (≥ 1 tooth with at least one site with ≥ 4 mm of clinical attachment loss (CAL) and presence of bleeding on probing) | 3. Extensive dental cavity (crowns of several teeth destroyed by caries) and loss of tooth structure or use of fixed dental braces |
4. Cognitively and physically able to complete an interview and oral examination and willing to participate, including provision of blood samples. | 4. Use of antibiotics or any immune-suppressants or medication known to affect vitamin D/calcium metabolism |
|  | 5. Consumption of ≥ 4 servings/day of dairy products or taking vitamin D supplements > 400 IU/day |