Li 2009.
| Methods |
RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): yes, parallel RCT RANDOMISATION RATIO: equal ratio assumed (not stated in manuscript) NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: yes PATIENT CONSENT OBTAINED: yes BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = unclear ANALYSIS BY INTENTION TO TREAT: no, ITT not reported in the paper POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): Insulin 27%F (5/18): 72% M (13/18), Insulin+Vit D 17.6% F (3/17) : 82.4% M(14/17) AGE (mean years (SD)): Insulin: 42.8 years (12.9), Insulin+Vit D 38.5 yrs (12.5) ETHNIC GROUPS (%): not stated DURATION OF DISEASE (median years (range)): insulin 0.5 yrs (0.1‐4.0), Insulin + Vit D 1.0 yrs (0.1‐4.0) INCLUSION CRITERIA: (1) age to onset over 20 years (2) no ketosis within the first 6 months after diagnosis (3) disease duration less than 5 years (4) autoantibodies to GADA positive twice within one month and (5) fasting C‐peptide (FCP) > 200 pmol/L at entry. EXCLUSION CRITERIA: (1) patients with liver or kidney disorders (alanine aminotransferase or aspartate aminotransferase > 2.5‐fold of upper normal limit, total bilirubin > 1.5 U/mL or blood creatinine > 15 mg/dL (2) premenopausal women who did not use effective contraception, or any pregnant women (3) patients who have had any severe systemic disease such as heart failure, cancer, stroke, or recent surgery. DIAGNOSTIC CRITERIA: Diabetes diagnosed according to American Diabetes Association (ADA) standards CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Insulin 18, Insulin+Vit D 17 LOSS TO FOLLOW‐UP: 0% |
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| Interventions |
NUMBER OF STUDY CENTRES:not given COUNTRY/ LOCATION: China SETTING: not given INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): both groups treated with mixed human Insulin (Novolin 30 R or Humulin 70/30). Vit D group was Alpha‐calcidol 0.25 ug bid for 12 months glibenclamide) and premix insulin for 8 months CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): both groups treated with mixed human Insulin (Novolin 30 R or Humulin 70/30). TREATMENT BEFORE STUDY:None TITRATION PERIOD:None |
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| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication): Not stated but objectives states "possible benefits of 1‐α‐hycroxyvitamin C3 combined with insulin on beta‐cell function" SECONDARY OUTCOMES (as stated in the publication):Not stated ADDITIONAL OUTCOMES: Collected at baseline and 12 months. 1. Fasting C‐peptide 2. 2‐h postprandial C‐peptide (PCP) |
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| Study details |
DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 12 months RUN‐IN PERIOD: none |
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| Publication details |
LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: no NON‐COMMERCIAL FUNDING: yes PUBLICATION STATUS (PEER REVIEW JOURNAL): yes PUBLICATION STATUS (JOURNAL SUPPLEMENT):no PUBLICATION STATUS (ABSTRACT): Full paper |
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| Stated aim for study | Quote " to study the possible benefits of 1‐α‐hydroxyvitamin D3 combined with insulin on β‐cell function in LADA" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Unblinded |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded but there was no evidence that the analyst was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No problems identified |
| Selective reporting (reporting bias) | High risk | HbA1c was not reported |
| Other bias | Low risk | No problems identified |