PregnancyNCT02621827
Vitamin D Half-life in Pregnancy and Lactation
A study testing Oral dose of stable isotope labeled 25(OH)D3 in people with Pregnancy and Lactation, run by Medical Research Council.
Trial summary
This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months post-partum in women who are exclusively breast-feeding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Oral dose of stable isotope labeled 25(OH)D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to May 2013
- 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
- All participants:
- Currently resident in West Kiang and planning to stay for the next 5 months
- Aged between 18 and 45 y
- Pregnancy:
- > 20 wk < 30 wk pregnant (gestational age assessment by ultrasound)
- Singleton fetus
- Lactation:
- Breast feeding
Who cannot join
- All participants:
- Severe anaemia (haemoglobin < 7 g/dL) (as per ENID protocol)
- Known sickle cell anaemia
- Known to be asthmatic or allergic to peanuts (already excluded from ENID)
- Known history of liver, kidney, gut or malabsorption problems
- Other chronic condition
Show all 18Show fewer
- On prescription medication
- Taking vitamin D supplements (> 200 IU/d)
- Broken bone in last 3 y
- Recent infection or illness (2 weeks prior to the start of a study period)
- Reported onset of menopause (already excluded from ENID)
- Malaria parasitemia (prior to study period)
- Unable to consent
- Pregnant:
- Pregnancy-related complications or on discretion of mid-wife
- Known HIV positive
- Lactation:
- Health problem of mother or infant that may affect feeding practices
About this study
This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months post-partum in women who are exclusively breast-feeding.
- Being tested
- Oral dose of stable isotope labeled 25(OH)D3
- Keywords
- vitamin D, Africa
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral dose of stable isotope labeled 25(OH)D3Other
At each measurement, women are given an oral dose of stable isotope labelled 25(OH)D3. Blood and urine samples are collected at baseline and on day 21 post-dose. Additional blood samples are collected post-dose on days 6,9,24,27 and 30.
| Study group | Role | What they receive |
|---|---|---|
| Non-pregnant, non-lactating (NPNL) | Experimental | NPNL women are age and parity matched to pregnant women. Each NPNL women is studied twice, approximately 3 months apart.
At each study period the participant receives (as the intervention) a single oral dose of stable isotope labeled 25(OH)D3. Receives: Other: Oral dose of stable isotope labeled 25(OH)D3 |
| Pregnant/Lactating | Experimental | Pregnant women receive (as the intervention) a single oral dose of stable isotope labeled 25(OH)D3. The same women are followed-up in lactation to repeat the same protocol. Receives: Other: Oral dose of stable isotope labeled 25(OH)D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of stable isotope labeled 25(OH)D3
The plasma half-life of 25(OH)D3 is calculated from the slope (k) of the disappearance of the stable isotope labeled 25(OH)D3 against time using the equation half-life=0.693/k
Measured: Samples collected on day 6, 9, 21, 24, 27 and 30 post-dose
Secondary outcomes (3)
Plasma concentration of vitamin D metabolites and related calciotropic hormones
Analytes: 25(OH)D3, 24,25(OH)2D3, 1,25(OH)2D, vitamin D binding protein, parathyroid hormone, albumin, ionised calcium, phosphate
Measured: Fasting plasma samples collected at baseline and 21 days post-dose
Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP)
2-hour fasting urine collection
Measured: Samples collected at baseline and 21 days post-dose
Weighed dietary intake
Dietary nutrient intakes assessed by 2-day weighed food diary and nutrient intakes calculated using DINO (diet in nutrients out) analysis programme (Fitt et al, 2015)
Measured: 2 days within 30 days of dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kerry Jones, Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621827
- Sponsor's protocol ID
- MRC SCC1229
- Status last verified
- Dec 2015
- First submitted
- 27 Nov 2015
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Half-life in Pregnancy and Lactation
- ClinicalTrials.gov ID
- NCT02621827
- Acronym / sponsor ID
- MRC SCC1229
- Keywords
- vitamin D, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Dec 2015 (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.
This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months post-partum in women who are exclusively breast-feeding.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pregnant, non-lactating (NPNL) | Experimental | Other: Oral dose of stable isotope labeled 25(OH)D3NPNL women are age and parity matched to pregnant women. Each NPNL women is studied twice, approximately 3 months apart. At each study period the participant receives (as the intervention) a single oral dose of stable isotope labeled 25(OH)D3. |
| Pregnant/Lactating | Experimental | Other: Oral dose of stable isotope labeled 25(OH)D3Pregnant women receive (as the intervention) a single oral dose of stable isotope labeled 25(OH)D3. The same women are followed-up in lactation to repeat the same protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Currently resident in West Kiang and planning to stay for the next 5 months
- Aged between 18 and 45 y
- > 20 wk < 30 wk pregnant (gestational age assessment by ultrasound)
- Singleton fetus
- Breast feeding
Key exclusion criteria (18 listed)
- Severe anaemia (haemoglobin < 7 g/dL) (as per ENID protocol)
- Known sickle cell anaemia
- Known to be asthmatic or allergic to peanuts (already excluded from ENID)
- Known history of liver, kidney, gut or malabsorption problems
- Other chronic condition
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 |
|---|---|---|
| Oral dose of stable isotope labeled 25(OH)D3At each measurement, women are given an oral dose of stable isotope labelled 25(OH)D3. Blood and urine samples are collected at baseline and on day 21 post-dose. Additional blood samples are collected post-dose on days 6,9,24,27 and 30. | Other | Non-pregnant, non-lactating (NPNL), Pregnant/Lactating |
Primary outcome
Plasma concentration of stable isotope labeled 25(OH)D3
Time frame: Samples collected on day 6, 9, 21, 24, 27 and 30 post-dose
The plasma half-life of 25(OH)D3 is calculated from the slope (k) of the disappearance of the stable isotope labeled 25(OH)D3 against time using the equation half-life=0.693/k
3 secondary outcomes
Plasma concentration of vitamin D metabolites and related calciotropic hormones
Time frame: Fasting plasma samples collected at baseline and 21 days post-dose
Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP)
Time frame: Samples collected at baseline and 21 days post-dose
Weighed dietary intake
Time frame: 2 days within 30 days of dose
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 4 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oral dose of stable isotope labeled 25(OH)D3 in people with Pregnancy and Lactation, run by Medical Research Council.
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 8 inclusion and 18 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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Plasma concentration of stable isotope labeled 25(OH)D3 (time frame: Samples collected on day 6, 9, 21, 24, 27 and 30 post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2015.