Wolters 2005.
| Methods | 2‐arm, parallel group, placebo controlled, double‐blind RCT. Duration of treatment 6 months, duration of follow‐up 6 months | |
| Participants |
Location: Germany, single centre Recruitment: recruited by newspaper advertisement in Hannover region. Institute of Food Science, University of Hanover Number randomised: not reported. Baseline measures were taken from 241 women. Data are reported for 220 who completed the study. Participant (baseline) characteristics (provided for those who completed):
Inclusion criteria: healthy females 60 years or older; no vitamin supplementation for two months before intervention; no medications that affect vitamin absorption on status at the time of enrolment Exclusion criteria: not reported |
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| Interventions |
Intervention (n=111): Vitamin capsule (Nobilin Q10) contained 150 mg vitamin C (calcium ascorbate), 50 mg magnesium (magnesium carbonate), 36 mg vitamin E (D‐ alfa‐tocopherol acetate), 34 mg niacin (nicotinamide), 16 mg pantothenic acid, 9 mg ß‐carotene, 3.4 mg pyridoxine (pyridoxine hydrochloride), 3.2 mg riboflavin, 2.4 mg thiamine (thiamine mononitrate), 400 µg folic acid (pteroyl glutamic acid), 200 µg biotin, 60 µg selenium (selenium‐enriched yeast), and 9 µg cobalamin (cyanocobalamin). One capsule/day at breakfast for 6 months Comparator group (n=109): placebo One capsule/day at breakfast for 6 months Use of additional interventions: 4.5% women received statin medication. |
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| Outcomes |
Primary Outcomes: Wechsler Adult Intelligence Scale‐Revised (WAIS III) Intelligence assessed by the Kurztest fuer Allgemeine Intelligenz (KAI) Mild up to severe memory disorders assessed by a subtest of the Berliner Amnesie Test (BAT) Secondary outcomes: levels of homocysteine and methylmalonic acid at baseline and end of treatment Eligible cognitive outcomes:
Function outcome extracted: none reported Quality of life outcome extracted: none reported Safety outcome extracted: none reported *: outcome data included in statistical analyses |
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| Notes |
Funding sources: Medicom Pharma. Vitamin capsules (Nobilin Q10R) and placebo capsules were donated by Medicom Pharma AG, Springe (Germany). Declarations of interest: no information provided |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Of these, 109 women had been randomly assigned to the placebo group and 111 women to the vitamin group by a lottery." Comment: unclear method of sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Of these, 109 women had been randomly assigned to the placebo group and 111 women to the vitamin group by a lottery." Comment: unclear method of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both capsules, the multivitamin and the placebo, were soft gelatine capsules filled with soy oil. The oil in the placebo capsule was colored for identical appearance." Comment: probably blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The cognitive tests were performed on the day of blood sampling after the women had had breakfast." Comment: blinding of outcome assessment not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 8.7% (21/241 assessed at baseline) dropped out, but it is unclear from which group. Two participants were excluded by the experimenters for non‐compliance. The total number of patients randomised was unclear. Only completers' data reported |
| Selective reporting (reporting bias) | Low risk | All primary and secondary outcomes specified in the Methods were reported. |
| Other bias | Unclear risk | There were baseline imbalances in educational level (higher in vitamin group) and Symbol Search (better in vitamin group). |