Condition category
Musculoskeletal Diseases
Date applied
04/04/2007
Date assigned
30/04/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Macdonald

ORCID ID

Contact details

Osteoporosis Research Unit
Health Sciences Building
University of Aberdeen
Osteoporosis Research Unit
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 559001
h.macdonald@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FSA project number: N05043

Study information

Scientific title

Acronym

ADAFVT (Aberdeen Dietary Acidity, Fruit and Vegetable Trial)

Study hypothesis

To test whether fruit and vegetable intake reduces the acidity of a mixed diet and the requirement of bone for buffering, or provide other dietary components important for bone health.

Ethics approval

Grampian Research Ethics Committee on 23/12/2002 (ref: 02/0053).

Study design

Two year placebo-controlled randomised trial (double blind for potassium citrate arms and single blind for fruit and vegetable arm).

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Low bone mass/risk of osteoporosis

Intervention

Minimisation criteria included key genotypes (vitamin D receptor genotype and Apolipoprotein E genotype, smoking and dietary acidity (calculated from protein to potassium ratio).

Group A: potassium citrate equivalent to 900 g fruit and vegetables (55.5 mEq)
Group B: potassium citrate equivalent to 300 g fruit and vegetables (18.5 mEq)
Group C: 300 g of fruit and vegetables
Group D: placebo

Duration of treatment was two years for each treatment arm.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Bone turnover markers:
a. serum N-terminal Propeptide of type 1 collagen (P1NP), measured at baseline, 3, 6, 12, 18 and 24 months
b. serum C-terminal telopeptide of type I collagen (CTX), measured at baseline, 3, 6, 12, 18 and 24 months
c. urinary free Deoxypyridinoline cross-links (fDPD), measured at baseline, 3, 6, 12, 18 and 24 months; women also posted a fasted urine sample 6 to 8 weeks after the baseline visit

Secondary outcome measures

Bone mineral density change over two years measured by DEXA at baseline and 24 months.

Overall trial start date

01/03/2003

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 55 years to 65 years who had taken part in a longitudinal study (Aberdeen Prospective Osteoporosis Screening Study). Includes:
1. Otherwise healthy women taking other types of diuretics (not potassium sparing diuretics) or hypertension tablets
2. Women on thyroxine treatment provided their thyroid function is stable (as assessed by free Thyroxine [T4] and Thyroid Stimulating Hormone [TSH] levels) and their dose had not changed in the year prior to study entry

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

260

Participant exclusion criteria

1. Suffering from severe disease
2. Malabsorption
3. Having difficulties swallowing tablets/capsules
4. Taking oral corticosteroids
5. On or past bisphosphonate treatment (more than a few weeks)
6. Taking Hormone Replacement Therapy (HRT) in the last six months
7. Less than five years past the menopause
8. Currently taking potassium-sparing diuretics
9. Osteoporosis diagnosed from Dual Energy X-ray Absorptiometry (DEXA) scan at baseline visit

Recruitment start date

01/03/2003

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Osteoporosis Research Unit
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

Food Standards Agency (UK)

Sponsor details

Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
alisdair.wotherspoon@foodstandards.gsi.gov.uk

Sponsor type

Government

Website

http://www.food.gov.uk

Funders

Funder type

Government

Funder name

Food Standards Agency (UK)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18689384

Publication citations

  1. Results

    Macdonald HM, Black AJ, Aucott L, Duthie G, Duthie S, Sandison R, Hardcastle AC, Lanham New SA, Fraser WD, Reid DM, Effect of potassium citrate supplementation or increased fruit and vegetable intake on bone metabolism in healthy postmenopausal women: a randomized controlled trial., Am. J. Clin. Nutr., 2008, 88, 2, 465-474.

Additional files

Editorial Notes