Combination therapy using calcium/vitamin D and protein/calorie supplements in nutritionally deficient women

ISRCTN	ISRCTN62937696
DOI	https://doi.org/10.1186/ISRCTN62937696
Secondary identifying numbers	AP0714

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Geeta Hampson
Scientific

Senior Lecturer
Department of Chemical Pathology
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7928 9292 ext 2881
Email	geeta.hampson@kcl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised controlled trial of combination therapy using calcium/vitamin D and protein/calorie supplements in nutritionally deficient women: an assessment of changes in osteoporotic fracture risk
Study objectives	To investigate the effects of dietary advice and nutritional supplementation on bone mineral density.
Ethics approval(s)	The Research Ethics Committee of the Guys and St Thomas Hospital NHS Trust gave approval
Health condition(s) or problem(s) studied	Osteoporosis
Intervention	Women meeting the entry criteria will be randomised to one of two groups: 1. A control group will receive calcium/vitamin D only 2. The second group will receive dietary advice and nutritional supplements to increase their dietary intake and calcium/vitamin D
Intervention type	Other
Primary outcome measure	Body composition and bone mineral density (BMD), assessed at baseline and 12 months.
Secondary outcome measures	Biochemical markers of bone turnover, measured at baseline and at 1, 3, 6, 9 and 12 months.
Overall study start date	01/09/1999
Completion date	31/08/2001

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	71
Key inclusion criteria	1. Women over 70 years 2. Body mass index of less than 21 kg/m^2 3. Osteoporosis at the femoral neck and/or total hip
Key exclusion criteria	1. Evidence of any progressive wasting disease, e.g. carcinomatosis, severe malabsorption 2. Severe renal impairment (estimated glomerular filtration rate [GFR] less than or equal to 45 ml/min) 3. Severe cardiorespiratory diseases 4. Endocrine diseases, e.g., hyperparathyroidism, hyperthyroidism 5. Therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, oestrogen, raloxifene 6. Cognitive impairment (abbreviated mental test score 7 or below)
Date of first enrolment	01/09/1999
Date of final enrolment	31/08/2001

Senior Lecturer

London
SE1 7EH
United Kingdom

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Website	http://www.action.org.uk/
"ROR"	https://ror.org/01wcqa315

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2003		Yes	No