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Trial registered on ANZCTR


Registration number
ACTRN12615001028594
Ethics application status
Approved
Date submitted
15/09/2015
Date registered
1/10/2015
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mother and Infant Nutrition Investigation - Investigating micronutrient intake and status in mothers and babies, and their possible effects on thyroid function
Scientific title
Micronutrient intake and status (iodine, selenium and iron) and their possible effects on thyroid function in postpartum women and their infants in New Zealand
Secondary ID [1] 287476 0
Nil
Universal Trial Number (UTN)
U1111-1173-9926
Trial acronym
MINI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Micronutrient deficiency 296218 0
Postnatal depression 296219 0
Thyroid function 296268 0
Condition category
Condition code
Diet and Nutrition 296491 296491 0 0
Other diet and nutrition disorders
Mental Health 296492 296492 0 0
Depression
Metabolic and Endocrine 296537 296537 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As an observational study, the objectives are to investigate postpartum women’s micronutrient intake and status (namely iodine, selenium and iron); investigating the effects of iodine, selenium and iron on thyroid function; investigating infant iodine and selenium status during the first year of life;and to what extent inadequate status of iodine, selenium and iron are associated with the risk of postnatal depression in participating women; investigating possible effects of iodine, selenium and iron status on early child development; investigating retrospective selenium status of postpartum women and their infants. The overall duration for mothers and their babies will be completed when the baby is 1 year old.
Intervention code [1] 292859 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296117 0
investigating postpartum women’s micronutrient status (namely iodine, selenium and iron) by testing urine, blood, breastmilk (if applicable) and nail samples;

Timepoint [1] 296117 0
When their infants are between 3 weeks and 3 months of age; When their infants are 6 months of age;
When their infants are 12 months of age
Secondary outcome [1] 317552 0
investigating to what extent inadequate status of iodine, selenium and iron assessed by testing urine and blood samples are associated with the risk of postnatal depression assessed by Edinburgh Postnatal Depression Scale in participating women;
Timepoint [1] 317552 0
When their infants are between 3 weeks and 3 months of age;
When their infants are 6 months of age;
When their infants are 12 months of age.
Secondary outcome [2] 317666 0
investigating postpartum women’s micronutrient intake (namely iodine, selenium and iron) by dietary assessment tools (including 4 day weighed dietary diary and Food Frequency Questionnaire;
Timepoint [2] 317666 0
When their infants are between 3 weeks and 3 months of age; When their infants are 6 months of age;
When their infants are 12 months of age
Secondary outcome [3] 317667 0
investigating infant selenium status (assessed by tesing urine samples) during the first year of life
Timepoint [3] 317667 0
When they are between 3 weeks and 3 months of age;
When they are 6 months of age;
When they are 12 months of age
Secondary outcome [4] 317668 0
investigating maternal health (assessed by designed questionnaire specificially for this study) and child development (the Ages and Stages Questionnaire) through the first year of the life
Timepoint [4] 317668 0
When their infants are between 3 weeks and 3 months of age;
When their infants are 6 months of age;
When their infants are 12 months of age;
Secondary outcome [5] 317670 0
investigating the retrospective selenium status of postpartum women and their infants by assessing nail clippings
Timepoint [5] 317670 0
When their infants are 6 months of age;
When their infants are 12 months of age
Secondary outcome [6] 317863 0
nvestigating the effects of iodine, selenium and iron (a composite, assessed by testing blood, urine and breastmilk samples) on thyroid function by serum assays
Timepoint [6] 317863 0
When their infants are between 3 weeks and 3 months of age;
when their infants are 6 months of age;
when their infants are 12 months of age
Secondary outcome [7] 317864 0
investigating infant iodine status (assessed by testing urine samples) during the first year of life
Timepoint [7] 317864 0
when they are between 3 weeks and 3 months of age;
when they are 6 months of age;
when they are 12 months of age.

Eligibility
Key inclusion criteria
The target population for the study is healthy women aged 16 years or older who have delivered a healthy term singleton infant. Since the study will follow participating mothers and their infants until the baby is 12 months old, continued participation requires that the infant does not contract or suffer from any serious on-going health problems.
Postpartum women's new born infants will be included in the study if they are healthy. These infants can be a boy or girl, and are aged between 3 weeks and 12 months.
Minimum age
3 Weeks
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women will be excluded if they develop significant health problems or severe chronic conditions; women will also be excluded if they have been treated for hyperthyroidism or hypothyroidism.
Postpartum women's new born infants will be excluded if if they are suffering from serious health conditions.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
The main outcome measure is iodine excreted per day with three repeated measurement of spot urine samples, and this is the basis for the sample size calculation using means and SD from our preliminary data utilising G*Power 3.1 (Heinrich Heine University, Dusseldorf). The NZDep2013 index of deprivation ordinal scale ranges from 1 to 10, where 1 represents the areas with the least deprived scores and 10 the areas with the most deprived scores, which will be divided into 5 socioeconomic groups. The analysis is based on using 1–way ANOVA with 5 socioeconomic groups (95% power, alpha = 0.05, two tailed). 180 participants will be required, using expected means for the groups of 100, 100, 100, 70 and 70 microgram/L (i.e. a maximum difference between groups of 30 microgram/L) and SD of 55 based on previous iodine study of breastfeeding women. We intend to over sample disadvantaged women as we expect more of these participants to drop out of the study.
Statistical analysis will be performed using IBM SPSS statistics 20 . Baseline data will be described using mean (standard deviation), median (25, 75 percentile) or frequencies summary statistics. ANOVA will be used to analysis the continuous variables.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7169 0
New Zealand
State/province [1] 7169 0
Lower North Island

Funding & Sponsors
Funding source category [1] 292052 0
University
Name [1] 292052 0
School of Food and Nutrition Postgraduate Funding, Massey University
Address [1] 292052 0
School of Food and Nutrition
Massey University
Riddet Reception
Riddet Road
Palmerston North 4474
New Zealand
or PO Box 11 222
Palmerston North 4442
New Zealand
Country [1] 292052 0
New Zealand
Funding source category [2] 297244 0
University
Name [2] 297244 0
Massey University Research Fund (MURF)
Address [2] 297244 0
College of Health, Massey University Manawatu
Private Bag 11 222
Palmerston North 4442
New Zealand
Country [2] 297244 0
New Zealand
Funding source category [3] 300203 0
Charities/Societies/Foundations
Name [3] 300203 0
Oakley Mental Health Research Fundation
Address [3] 300203 0
PO Box 302499

North Harbour

Auckland 0751
Country [3] 300203 0
New Zealand
Primary sponsor type
Individual
Name
Ying Jin
Address
School of Food and Nutrition
Massey University
Riddet Complex
Riddet Road, Massey University
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 290725 0
University
Name [1] 290725 0
Massey University
Address [1] 290725 0
School of Food and Nutrition
Massey University
Riddet Reception
Riddet Road
Palmerston North 4474
New Zealand
Country [1] 290725 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293534 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 293534 0
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 293534 0
New Zealand
Date submitted for ethics approval [1] 293534 0
06/10/2015
Approval date [1] 293534 0
18/11/2015
Ethics approval number [1] 293534 0
15/NTA/172
Ethics committee name [2] 295898 0
Royal New Zealand Plunket Society Ethics Committee
Ethics committee address [2] 295898 0
Plunket National Office,
Level 3 Simp House
40 Mercer Street
Wellington 6011
Ethics committee country [2] 295898 0
New Zealand
Date submitted for ethics approval [2] 295898 0
03/06/2016
Approval date [2] 295898 0
29/06/2016
Ethics approval number [2] 295898 0

Summary
Brief summary
The objective of this study is to investigate intake and status of micronutrients (iodine, selenium, and iron) and to explore effects on thyroid function and risk of postnatal depression in postpartum women and their infants, resident in the lower North Island of New Zealand. This follows two recent government initiatives - mandatory fortification of bread with iodised salt in September 2009; and the provision of an iodine supplement for all pregnant and lactating women from July 2011. The study aims are to analyse postpartum women’s iodine, selenium, iron intake and status, measure whether multiple micronutrient deficiencies may adversely affect thyroid function; assess whether postpartum women remain iodine deficient despite the two recent government initiatives; investigate to what extent inadequate status of iodine, selenium and iron are associated with the risk of postnatal depression in participating women, which, subsequently, may adversely affect their infant’s development. Iodine is an important trace element for both postpartum women and their infants; iodine deficiency has been described as the single greatest cause of preventable mental impairment. Coexisting inadequacy of iodine, selenium, and iron status has been suggested to impair optimal thyroid function. It is important to investigate the intakes and status of iodine, selenium, and iron together, rather than investigating a single micronutrient in isolation. We will recruit 250 postpartum women (at least 3 weeks to 3 months postpartum) of a range of ethnicities and socio-economic backgrounds, within the lower North island of New Zealand. Dietary assessment will be used to collect data about intake of selected micronutrients. Maternal health and child development through the first year of the life will be assessed by questionnaires. Biological samples (urine, breast milk and blood samples and nail clippings) will be collected to measure micronutrient status and thyroid function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60354 0
Ms Ying Jin
Address 60354 0
School of Food and Nutrition
Massey University
Riddet Reception
Riddet Road
Palmerston North 4474
New Zealand
Country 60354 0
New Zealand
Phone 60354 0
+64 6 951 7556
Fax 60354 0
Email 60354 0
y.jin@massey.ac.nz
Contact person for public queries
Name 60355 0
Ms Ying Jin
Address 60355 0
School of Health Science Massey University Riddet Reception Riddet Road Palmerston North 4474 New Zealand
Country 60355 0
New Zealand
Phone 60355 0
+64 6 951 7556
Fax 60355 0
Email 60355 0
y.jin@massey.ac.nz
Contact person for scientific queries
Name 60356 0
Ms Ying Jin
Address 60356 0
School of Health Science Massey University Riddet Reception Riddet Road Palmerston North 4474 New Zealand
Country 60356 0
New Zealand
Phone 60356 0
+64 6 951 7556
Fax 60356 0
Email 60356 0
y.jin@massey.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary