Table 2.
Current concerns and recommendations for future RCT’s designing.
No. | Concerns Related to Existing Clinical Study Data | Recommendations for Future RCT’s Designing |
---|---|---|
1. | Follow-up too short | Follow-up > 12 months |
2. | Too high, too low, non-physiological, and not frequent enough doses of vitamin D | Sufficiently large doses, consistent with the recommendations for a given population |
3. | Lack of reported exclusion criteria or a wide variety of exclusion criteria inconsistent between studies | Medications, current medical diseases, participant’s past medical history, which could potentially influence glucose or vitamin D metabolism, and mental illnesses routinely included in the exclusion criteria beside any relevant others |
4. | Different endpoints and glycemic parameters measured | Ideal primary endpoint: diabetes mellitus type 2 developmentThe measured parameters should be consistent with prediabetes criteria established by scientific societies |
5. | Vitamin D levels in participants not assessed or participants with normal levels of vitamin D included in study groups together with vitamin D deficient participants | Only participants with hypovitaminosis D divided into levels of this deficiency should be considered in order to get reliable results |
6. | Study groups not homogenous regarding: diabetes status | Only patients with diabetes or with prediabetes in one study group |
7. | Wide age-range and different ethnicity | Homogenous groups analyzed together |
8. | Additional interventions in one study | Vitamin D supplementation should be the only intervention; neither lifestyle change nor co-supplementation should be included in study designs, not allowing for separating the effects of individual interventions |
9. | Not reporting or assessing sun exposure, the seasons, and geographical location in which the study was performed | Inclusion of sun exposure, seasons, and geographical locations data with respect to vitamin D and participants |