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A randomised double-blind parallel-group study evaluating effcacy and safety on MEGA tablets compared to Kalcipos® tablets in adult subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72183044
Enrollment
56
Registered
2007-09-19
Start date
2007-01-05
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild or moderate vitamin D deficiency Nutritional, Metabolic, Endocrine Vitamin D deficiency

Interventions

Supplementation with either calcium and vitamin D or calcium alone. The subjects will be treated with two tablets per day for twelve months. The allocation of subjects to treatment, study product (vit

Sponsors

Recip AB (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women 55 to 85 years of age 2. Mild or moderate vitamin D insufficiency (serum 25-hydroxy-vitamin D 10-70 nmol/L)

Exclusion criteria

Exclusion criteria: 1. Subjects with severe vitamin D deficiency (serum 25-hydroxy-vitamin D below 10 nmol/L) 2. Suspected osteomalacia 3. Serious diseases or drug treatments that may interfere with study results

Design outcomes

Primary

MeasureTime frame
Serum levels of 25-hydroxyvitamin D, measured at baseline, 3, 6, 9 and 12 months.

Secondary

MeasureTime frame
1. Serum levels of parathyroid hormone and biochemical bone markers, measured at baseline, 6 and 12 months 2. Safety, measured at baseline, 3, 6, 9 and 12 months

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026