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Effect of vitamin K supplementation on bone mineral density and bone turnover, and on markers of soft tissue calcification in Greek postmenopausal women.


- candidate number3804
- NTR NumberNTR1396
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-aug-2008
- Secondary IDs62007, date of approval METC Harokopio Univ Athens 
- Public TitleEffect of vitamin K supplementation on bone mineral density and bone turnover, and on markers of soft tissue calcification in Greek postmenopausal women.
- Scientific TitleEffect of vitamin K supplementation on bone mineral density of the spine and hip, on markers of osteoblast and osteoclast activity, and on markers of soft tissue calcification, in Greek postmenopausal women.
- ACRONYMN/A
- hypothesisVitamin K2 is more effective than K1 in reducing osteoclast activity, and in the carboxylation of osteocalcin and MGP
- Healt Condition(s) or Problem(s) studiedBone mineral density (BMD), Postmenopausal women, Bone turnover, Vitamin K, Menaquinones, Greek
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2008
- planned closingdate31-dec-2009
- Target number of participants140
- Interventions- 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.
- 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
- Timepoints- 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
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. Schaafsma
- CONTACT for SCIENTIFIC QUERIES Y. Manios
- Sponsor/Initiator Friesland Foods, Leeuwarden (Global Development Centre)
- Funding
(Source(s) of Monetary or Material Support)
Friesland Foods
- PublicationsN/A
- Brief summaryVitamin 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.
- Main changes (audit trail)
- RECORD6-aug-2008 - 4-sep-2008


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