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ID
Source
Brief title
Health condition
Postmenopausal women, bone loss, bone turnover, vitamin K, menaquinones, bone mineral density, Greek
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Bone mineral density of hip and spine
- Effect on parameters of bone turnover in blood and urine
Secondary outcome
- Carboxylation of MGP
- Anthropometry
Background summary
Vitamin K is essential for the carboxylation of among others osteocalcin and Matrix gla protein. The type of vitamin K might have an important impact on effectivity. Vitamin K1 has shown to be effective with regard to bone but is also very effective in the system of blood clotting. Especially for patients on anti-clotting therapy enrichment with vitamin K1 might cause problems. Vitamin K2, and especially the longer menoquinones are thought to be more specialized with regard to the carboxylation reactions whereas the effect on blood clotting is minimalized. This study investigates the difference between equal doses of vitamin K1 and K2 (MK-7) on carboxylation of osteocalcin and matrix gla, on bone mineral density and on markers of osteoblast and osteoclast activity. Furthermore, this study will provide us safety data on long term use of vitamin K1 versus vitamin K2. The study will be performed in apparently healthy Greek postmenopausal women and will last for 12 months.
Study objective
Vitamin K2 is more effective than K1 in reducing osteoclast activity, and in the carboxylation of osteocalcin and MGP
Study design
- BMD, blood, urine: 0 (start) and 12 months
- Ca FFQ: 0, 6 and 12 months
- Dietary recall: 0, 6 and 12 months
- Length and weight: 0, 3, 6, 9, and 12 months
Intervention
- No intervention
- Dairy product low vitamin K
- Dairy product + 100 mcg vitamin K1
- Dairy product + 100 mcg vitamin K2
Number of participants per intervention group:
There will be two intervention groups, one placebo group, and one not-supplemented group. Each group will have at least 25 participants.
Pieter Stuyvesantweg 1
Leeuwarden 8937 AC
The Netherlands
+31 (0)6 53241313
anne.schaafsma@frieslandfoods.com
Pieter Stuyvesantweg 1
Leeuwarden 8937 AC
The Netherlands
+31 (0)6 53241313
anne.schaafsma@frieslandfoods.com
Inclusion criteria
1. Apparently healty Greek
2. Postmenopausal women
3. Age 55-70 years
4. Postmenopausal for >5 years
5. T-score lumbar spine based on DXA >-2.5
6. Habitual calcium intake =<800 mg/day
7. Cigarettes <5 per day
8. BMI perferable <30
9. Willing to complete a 12 month study and product (milk) consumption
Exclusion criteria
1. Postmenopausal for <5 years (menses during the last 60 months)
2. Age <55 years
3. T-score lumbar spine =<-2.5
4. Use of medicines/supplements that interfere with bone metabolism, such as estrogens and vitamin D supplements
5. No evident arthrosis of spine and hip
6. Absence of acute and chronic illnesses
7. Calcium intake >800 mg/day
8. Cigarettes >5/day
9. BMI >33
10. Lactose intolerant
11. Cow's milk protein allergy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1338 |
| NTR-old | NTR1396 |
| Other | : 62007, date of approval METC Harokopio Univ Athens |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |