Calcium supplementation on blood glucose, lipids and obesity in Chinese women

ISRCTN	ISRCTN74325268
DOI	https://doi.org/10.1186/ISRCTN74325268
Secondary identifying numbers	N/A

Submission date: 14/09/2011
Registration date: 07/10/2011
Last edited: 30/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims:
In the last 20 years, in China, calcium supplementation is common and is recommended for postmenopausal women to prevent osteoporosis and improve health. However, until now, there have not been any systematic studies to show the effect of calcium supplements on Chinese womens health. The aim of this study is to investigate the effect of calcium supplementation on blood glucose, fat levels and obesity in Chinese women.

Who can participate?
Females aged 30 - 60 years with a stable body weight during 6 months before the study.

What does the study involve?
Participants were first sorted by age and then randomly allocated into two groups (calcium supplements group and controlled group). The subjects in the calcium supplements group received a calcium tablet each day to take after supper. Those in the other group took a dummy tablet each day, which looked like the calcium tablet, but did not contain any calcium. This was also to be taken after supper. At the end of the study, participants were asked to provide blood samples to see if these tablets had an effect on the participants metabolism on their body and the effect on other body functions.

What are the possible benefits and risks of participating?
Those who received the calcium supplements may be at a lower risk of osteoporosis. There may be bruising and discomfort at the site of the blood test as with any blood test. However, the amounts of blood we took were small enough that they should not cause anaemia or make the subjects feel fatigue.

Where is the study run from?
Department of Nutrition and Food Hygiene, Harbin Medical University.

When is the study starting and how long is it expected to run for?
The study started in December 2008 and ended in December 2009.

Who is funding the study?
Danone Institute China - Diet Nutrition Research and Communication Grant ref: DIC2008-05

Who is the main contact?
Li Ying
liying_helen@163.com

Contact information

Prof Li Ying
Scientific

157 Baojian Road
Nangang District
Harbin
150081
China

Phone	+86 (0)451 8750 2731
Email	liying_helen@163.com

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of calcium supplementation on blood glucose, lipids and obesity in Chinese women: a double-blind, placebo-controlled trial
Study objectives	A number of studies of calcium supplements on prevention of osteoporosis, weight reduction, improvements in blood glucose and lipids profiles have been researched in the past several decades. However, no definite conclusion was obtained on the effects of calcium supplements on human health. In China, calcium supplementation is prevalent and especially recommended for postmenopausal women to prevent osteoporosis and improve health for the last 20 years. No systematic conclusion of calcium supplements on Chinese womens health has been obtained so far. We therefore carried out this project to evaluate calcium supplementation on blood glucose, lipids and obesity in Chinese women.
Ethics approval(s)	Medical Ethical Committee of Public Health College, Harbin Medical University approved on 20 November 2008 (ref: 2008013)
Health condition(s) or problem(s) studied	Obesity, blood glucose and lipids
Intervention	Eligible subjects were first sorted by age and then randomized into two groups with a block size of 2, with random numbers generated by statistical software SPSS. The subjects in the calcium supplements group received a 1500mg calcium carbonate tablet (containing 600mg calcium) 30 minutes after supper once daily. The subjects in placebo group took a placebo tablet (starch) instead of calcium carbonate at the same times and amounts as in the intervention group. The intervention lasted for 1 year.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Calcium carbonate
Primary outcome measure	1. The effects of calcium supplementation on glucose metabolism: fasting glucose and insulin, 2-hour post prandial glucose, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) and glycated hemoglobin (HbA1c) (%) 2. The effects of calcium supplementation on lipids metabolism: 2.1. Serum cholesterol, Triglyceride, HDL cholesterol (HDL-C), low-density-lipoprotein cholesterol (LDL-C), apolipoprotein A-I (Apo A-I) and Apolipoprotein B (Apo B) 2.2. Serum lipoprotein lipase (LPL) and adipocyte fatty acid-binding protein (AFABP) 2.3. Serum free fatty acid (FFA) profile 3. The effect on obesity: anthropometric indexes 4. Serum calcium relative indexes, including parathyroid hormone (PTH), 1.25-hydroxyvitamin D3, serum calcium, thyrocalcitonin and serum phosphate
Secondary outcome measures	1. Baseline characteristics: age, gender, body mass index (BMI), blood pressure and physical activity level 2. Daily intake of nutrients by the subjects at baseline and after 1 year intervention 3. Blood biochemistry characteristics of the subjects at baseline and after 1-year intervention: red blood cell, white blood cell, hemoglobin, total protein, albumin, urea nitrogen, creatinine, alanine transaminase and aspartate transaminase
Overall study start date	16/12/2008
Completion date	15/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Recruited 400
Key inclusion criteria	1. Aged 30-60 years, healthy female 2. Stable body weight during 6 months before the study
Key exclusion criteria	1. A history of cerebrovascular, cardiovascular, renal, hepatic, diabetes, or other medical diseases likely to interfere with the study 2. Taking medications, which were likely to interfere with the study 3. Received calcium supplements at least for one year before the beginning of the study 4. Pregnant or breast-feeding 5. Information incompleted or unwillingness to attempt to comply with the intervention
Date of first enrolment	16/12/2008
Date of final enrolment	15/12/2009

Locations

Countries of recruitment

China

Study participating centre

157 Baojian Road

Harbin
150081
China

Sponsor information

Harbin Medical University (China)
University/education

c/o Prof Li Ying
Public Health College
157 Baojian Road
Nangang District
Harbin
150081
China

Phone	+86 (0)451 8750 2731
Email	liying_helen@163.com
Website	http://www.hrbmu.edu.cn/english/index.htm
"ROR"	https://ror.org/05jscf583

Funders

Funder type

Research organisation

Danone Institute (China) - Diet Nutrition Research and Communication Grant (ref: DIC2008-05)

No information available

Results and Publications

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