Micronutrient DeficiencyNCT02756026
Assessing the Quality of Breast Milk
A study testing Multiple micronutrient supplement (Nutri-Fem) in people with Micronutrient Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in Bangladesh.
Trial summary
The purpose of the study is to establish a protocol for collecting representative samples of breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN) supplementation on milk MN concentrations. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiency
- What is being tested?
- Multiple micronutrient supplement (Nutri-Fem)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBangladesh
- Study dates
- Sep 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >18.5 Healthy
- In the 2nd to 4th month of lactation and breastfeeding ≥12 times/d
- Breast-feeding only one infant
- Non-pregnant
- Willing to spend 4 days and nights at the metabolic unit
- Willing to perform the procedures of BM collection using the breast pump.
Who cannot join
- Severe anemia (Hb <90 g/L) by HemoCue
- Currently taking micronutrient supplements
- Current pregnancy
- Current illness
- Current Mastitis
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka
About this study
The purpose of the study is to establish a protocol for collecting representative samples of breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN) supplementation on milk MN concentrations. The investigators will determine which breastfeeding episode during the 24 hour period best represents the maternal status; and within the episode whether fore, mid or hind milk samples be collected in future studies.
Read the detailed description
Mother-infant pairs were recruited in the peri urban area of Dhaka, Bangladesh to participate in a protocol development study at International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). The participants will spend 5 days in a metabolic unit of icddr,b and the procedures are as follows:
- On day 1, mother-infant pairs will come to the facility, consume their evening meal and spend the night.
- On day 2, the mothers will be asked to breastfeed their infant from one breast for as long as the infant is interested. An electric breast pump will be placed simultaneously on the other breast for a Full Milk (FM) collection. For the duration of the study the same breast will be used for feeding the infant the other breast will be used for the FM collection. Three separate aliquots of fore milk (up to 1 minute), mid (50 mL), and hind (until the breast is empty) milk will be collected by a special funnel attached to the breast pump. A 5 mL aliquot of BM will be removed from each the 3 aliquots for creamatocrit measurement and later vitamin and mineral determinations. The remainder of the pumped breast milk will be pooled and given to the mother to feed to her infant. A fasting blood sample (7 mL) will be obtained by venipuncture to measure maternal MN status. A breakfast meal will be served to the mother after the first feeding and the blood draw. The mother will be asked to refrain from breastfeeding her infant for the next 2-3 hours then the collection procedure will be repeated until the mother goes to sleep at night, and at any time during the night that the mother wakes to feed her infant. The meals for breakfast, lunch and dinner will be low in micronutrients.
- On day 3, the mothers will be given one commercial multiple micronutrient supplement tablet containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 2. The meals for breakfast, lunch and dinner will be low in micronutrients. Between breast milk collections the staff will collect maternal and infant anthropometry data, and administer Food Frequency (FF) and morbidity questionnaires.
- On day 4, the mothers will be given two commercial multiple micronutrient supplement tablets containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 3. The meals for breakfast, lunch and dinner will be low in micronutrients.
- On day 5, the study will end with a final collection of BM in the morning and the study participants will be discharged from the facility.
- Conditions
- Micronutrient Deficiency
- Being tested
- Multiple micronutrient supplement (Nutri-Fem)
- Keywords
- Breast milk, mineral, vitamin
- Medical subject headings
- Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient supplement (Nutri-Fem)Dietary supplement
Multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA).
| Study group | Role | What they receive |
|---|---|---|
| Micronutrient supplementation | Experimental | On day 3, all mothers are given a commercial multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA).
On day 4, all mothers are given two commercial multiple micronutrient supplements (Nutri-Fem) manufactured by Thorne, containing twice the Recommended Dietary Intake (RDA). Receives: Dietary Supplement: Multiple micronutrient supplement (Nutri-Fem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breast Milk Content of Cobalamin (Vitamin B12)
Vitamin B12 (ng/L) is measured in breast milk by quantitative immunoassay
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Secondary outcomes (9)
Plasma Cobalamin (Vitamin B12)
Vitamin B12 (pmol/L) is measured in plasma by automated immunoassay
Measured: Measured once in a fasting blood sample collected on day 2
Plasma Folate
Folate (nmol/L) is measured in plasma by automated immunoassay
Measured: Measured once in a fasting blood sample collected on day 2
Change in Breast Milk Content of Thiamin
Thiamin in breast milk (ug/L) is measured as Thiamin, Thiamin-monophosphate, and Thiamin-pyrophosphate by high performance liquid chromatography (HPLC)
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Riboflavin
Riboflavin in breast milk (ug/L) is measured as Riboflavin and Flavin adenine dinucleotide by ultra-performance liquid chromatography followed by tandem mass spectrometry (UPLC-MS/MS)
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Niacin
Niacin in breast milk (ug/L) is measured as Nicotinamide by UPLC-MS/MS
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Vitamin B6
Vitamin B6 in breast milk (ug/L) is measured as Pyridoxal by UPLC-MS/MS
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Vitamin A
Vitamin A in breast milk (nmol/L) is measured as retinol and beta-carotene by HPLC
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Vitamin E
Vitamin E in breast milk (nmol/L) is measured as alpha-tocopherol and gamma-tocopherol by HPLC
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of fat
Fat in breast milk (g/L) is measured using a creamatocrit.
Measured: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Micronutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Lindsay H Allen, PhD, Principal investigator, USDA, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756026
- Sponsor's protocol ID
- BMQ
- Other IDs
- 429296-1
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hampel D, Shahab-Ferdows S, Islam MM, Peerson JM, Allen LH. Vitamin Concentrations in Human Milk Vary with Time within Feed, Circadian Rhythm, and Single-Dose Supplementation. J Nutr. 2017 Apr;147(4):603-611. doi: 10.3945/jn.116.242941. Epub 2017 Feb 15.
PubMed 28202638
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Quality of Breast Milk
- ClinicalTrials.gov ID
- NCT02756026
- Acronym / sponsor ID
- BMQ
- Conditions
- Micronutrient Deficiency
- Keywords
- Breast milk, mineral, vitamin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to establish a protocol for collecting representative samples of breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN) supplementation on milk MN concentrations. The investigators will determine which breastfeeding episode during the 24 hour period best represents the maternal status; and within the episode whether fore, mid or hind milk samples be collected in future studies.
Detailed description
Mother-infant pairs were recruited in the peri urban area of Dhaka, Bangladesh to participate in a protocol development study at International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). The participants will spend 5 days in a metabolic unit of icddr,b and the procedures are as follows:
- On day 1, mother-infant pairs will come to the facility, consume their evening meal and spend the night.
- On day 2, the mothers will be asked to breastfeed their infant from one breast for as long as the infant is interested. An electric breast pump will be placed simultaneously on the other breast for a Full Milk (FM) collection. For the duration of the study the same breast will be used for feeding the infant the other breast will be used for the FM collection. Three separate aliquots of fore milk (up to 1 minute), mid (50 mL), and hind (until the breast is empty) milk will be collected by a special funnel attached to the breast pump. A 5 mL aliquot of BM will be removed from each the 3 aliquots for creamatocrit measurement and later vitamin and mineral determinations. The remainder of the pumped breast milk will be pooled and given to the mother to feed to her infant. A fasting blood sample (7 mL) will be obtained by venipuncture to measure maternal MN status. A breakfast meal will be served to the mother after the first feeding and the blood draw. The mother will be asked to refrain from breastfeeding her infant for the next 2-3 hours then the collection procedure will be repeated until the mother goes to sleep at night, and at any time during the night that the mother wakes to feed her infant. The meals for breakfast, lunch and dinner will be low in micronutrients.
- On day 3, the mothers will be given one commercial multiple micronutrient supplement tablet containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 2. The meals for breakfast, lunch and dinner will be low in micronutrients. Between breast milk collections the staff will collect maternal and infant anthropometry data, and administer Food Frequency (FF) and morbidity questionnaires.
- On day 4, the mothers will be given two commercial multiple micronutrient supplement tablets containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 3. The meals for breakfast, lunch and dinner will be low in micronutrients.
- On day 5, the study will end with a final collection of BM in the morning and the study participants will be discharged from the facility.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micronutrient supplementation | Experimental | Dietary Supplement: Multiple micronutrient supplement (Nutri-Fem)On day 3, all mothers are given a commercial multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA). On day 4, all mothers are given two commercial multiple micronutrient supplements (Nutri-Fem) manufactured by Thorne, containing twice the Recommended Dietary Intake (RDA). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI >18.5 Healthy
- In the 2nd to 4th month of lactation and breastfeeding ≥12 times/d
- Breast-feeding only one infant
- Non-pregnant
- Willing to spend 4 days and nights at the metabolic unit
Key exclusion criteria (5 listed)
- Severe anemia (Hb <90 g/L) by HemoCue
- Currently taking micronutrient supplements
- Current pregnancy
- Current illness
- Current Mastitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple micronutrient supplement (Nutri-Fem)Multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA). | Dietary supplement | Micronutrient supplementation |
Primary outcome
Change in Breast Milk Content of Cobalamin (Vitamin B12)
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Vitamin B12 (ng/L) is measured in breast milk by quantitative immunoassay
9 secondary outcomes
Plasma Cobalamin (Vitamin B12)
Time frame: Measured once in a fasting blood sample collected on day 2
Plasma Folate
Time frame: Measured once in a fasting blood sample collected on day 2
Change in Breast Milk Content of Thiamin
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Riboflavin
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Niacin
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Vitamin B6
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Vitamin A
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of Vitamin E
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Change in Breast Milk Content of fat
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Derived from this study: PubMed 28202638Hampel D, Shahab-Ferdows S, Islam MM, Peerson JM, Allen LH. Vitamin Concentrations in Human Milk Vary with Time within Feed, Circadian Rhythm, and Single-Dose Supplementation. J Nutr. 2017 Apr;147(4):603-611. doi: 10.3945/jn.116.242941. Epub 2017 Feb 15.
- Individual participant dataSharing planned: Undecided
Related trials for Micronutrient Deficiency
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Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay H Allen, PhD principal investigator
USDA, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple micronutrient supplement (Nutri-Fem) in people with Micronutrient Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breast Milk Content of Cobalamin (Vitamin B12) (time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.